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Example ResearchStudy/example-ctgov-study-record (XML)

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeCompartments: No defined compartments

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ClinicalTrials.gov Study Record (id = "example-ctgov-study-record")

<?xml version="1.0" encoding="UTF-8"?>

<ResearchStudy xmlns="http://hl7.org/fhir">
  <id value="example-ctgov-study-record"/> 
  <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"><p> <b> Generated Narrative: ResearchStudy</b> <a name="example-ctgov-study-record"> </a> </p> <div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border:
       1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ResearchStudy &quot;example-ctgov-study-record&quot; </p> </div> <p> <b> url</b> : <a href="https://fevir.net/resources/ResearchStudy/112103">https://fevir.net/resources/ResearchStudy/112103</a> </p> <p> <b> identifier</b> : FEvIR Object Identifier: 112103, id: NCT05503693 (use: OFFICIAL), id: AP303-PK-01</p> <p> <b> name</b> : NCT05503693_FHIR_Transform</p> <p> <b> title</b> : A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects</p> <h3> Labels</h3> <table class="grid"><tr> <td style="display: none">-</td> <td> <b> Type</b> </td> <td> <b> Value</b> </td> </tr> <tr> <td style="display: none">*</td> <td> Official Title <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </td> <td> A Single-center Randomized Double-blind Placebo-controlled Study to Investigate
             the Safety Tolerability and PK of SAD and MAD of AP303 Following Oral Administration
             and the Effect of Food on the PK of AP303 in Healthy Subjects</td> </tr> </table> <blockquote> <p> <b> relatedArtifact</b> </p> <p> <b> type</b> : transforms</p> <blockquote> <p> <b> document</b> </p> </blockquote> </blockquote> <blockquote> <p> <b> relatedArtifact</b> </p> <p> <b> type</b> : transformed-with</p> <p> <b> display</b> : Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter</p> <blockquote> <p> <b> document</b> </p> </blockquote> </blockquote> <p> <b> status</b> : active</p> <p> <b> primaryPurposeType</b> : Treatment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-prim-purp-type.html">ResearchStudyPrimaryPurposeType</a> #treatment)</span> </p> <p> <b> phase</b> : Phase 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-phase.html">ResearchStudyPhase</a> #phase-1)</span> </p> <p> <b> studyDesign</b> : Design Masking: Quadruple <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> , Design Who Masked: Participant <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> , Design Who Masked: Care Provider <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> , Design Who Masked: Investigator <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> , Design Who Masked: Outcomes Assessor <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> , Design Allocation: Randomized <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> , Design Intervention Model: Sequential Assignment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> , CT.gov StudyType: INTERVENTIONAL <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </p> <p> <b> condition</b> : Healthy Subjects <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </p> <p> <b> keyword</b> : Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </p> <p> <b> descriptionSummary</b> : This is a single-center, randomized, double-blind, placebo-controlled, first-in-human
         study in which the safety, tolerability, and pharmacokinetics of orally administered
         AP303 will be assessed in healthy adult subjects.</p> <p> <b> description</b> : The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase
         enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending
         doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A
         will receive AP303 under both fasted and fed conditions to investigate the effect
         of food.</p> <p> <b> site</b> : <a name="NCT05503693-Location-0-ResearchStudy"> </a> </p> <blockquote> <p/>  <p> <a name="NCT05503693-Location-0-ResearchStudy"> </a> </p> <p> <b> partOf</b> : <a href="#">#</a> </p> <p> <b> status</b> : active</p> <p> <b> site</b> : <a href="#NCT05503693-Location-0">#NCT05503693-Location-0</a> </p> <h3> ProgressStatuses</h3> <table class="grid"><tr> <td style="display: none">-</td> <td> <b> State</b> </td> </tr> <tr> <td style="display: none">*</td> <td> Recruiting <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="codesystem-research-study-status.html">Research Study Status</a> #recruiting)</span> </td> </tr> </table> </blockquote> <p> <b> classifier</b> : Has Results: False <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> , Oversight Classifier: oversightHasDmc Yes <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> , Oversight Classifier: isFdaRegulatedDrug No <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> , Oversight Classifier: isFdaRegulatedDevice No <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </p> <blockquote> <p> <b> associatedParty</b> </p> <p> <b> name</b> : Alebund Pharmaceuticals</p> <p> <b> role</b> : Sponsor <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="codesystem-research-study-party-role.html">Research Study Party Role</a> #sponsor)</span> </p> <p> <b> classifier</b> : INDUSTRY <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </p> </blockquote> <blockquote> <p> <b> associatedParty</b> </p> <p> <b> name</b> : Alebund Pty Ltd</p> <p> <b> role</b> : lead-sponsor <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="codesystem-research-study-party-role.html">Research Study Party Role</a> #lead-sponsor)</span> </p> <p> <b> classifier</b> : INDUSTRY <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </p> </blockquote> <blockquote> <p> <b> associatedParty</b> </p> <p> <b> name</b> : Zhen LIU</p> <p> <b> role</b> : recruitment-contact <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="codesystem-research-study-party-role.html">Research Study Party Role</a> #recruitment-contact)</span> </p> <p> <b> classifier</b> : Contact <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </p> <p> <b> party</b> : <a name="NCT05503693-CentralContact-0"> </a> </p> <blockquote> <p/>  <p> <a name="NCT05503693-CentralContact-0"> </a> </p> <p> <b> name</b> : Zhen LIU</p> <p> <b> telecom</b> : ph: 86 021-60836212, <a href="mailto:clinicaloperation@alebund.com">clinicaloperation@alebund.com</a> </p> </blockquote> </blockquote> <blockquote> <p> <b> associatedParty</b> </p> <p> <b> name</b> : Sam Francis, Doctor</p> <p> <b> role</b> : Principal Investigator <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </p> <p> <b> party</b> : <span> : Nucleus Network</span> </p> </blockquote> <blockquote> <p> <b> progressStatus</b> </p> <p> <b> state</b> : Recruiting <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="codesystem-research-study-status.html">Research Study Status</a> #recruiting)</span> </p> </blockquote> <blockquote> <p> <b> progressStatus</b> </p> <p> <b> state</b> : Overall Study <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="codesystem-research-study-status.html">Research Study Status</a> #overall-study)</span> </p> <p> <b> actual</b> : false</p> <p> <b> period</b> : 2022-12-06 --&gt; 2023-06</p> </blockquote> <h3> Recruitments</h3> <table class="grid"><tr> <td style="display: none">-</td> <td> <b> TargetNumber</b> </td> <td> <b> Eligibility</b> </td> </tr> <tr> <td style="display: none">*</td> <td> 62</td> <td> <a href="broken-link.html">https://fevir.net/resources/EvidenceVariable/112075</a> </td> </tr> </table> <blockquote> <p> <b> comparisonGroup</b> </p> <p> <b> linkId</b> : ap303</p> <p> <b> name</b> : AP303</p> <p> <b> type</b> : Experimental <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </p> <p> <b> description</b> : AP303</p> <p> <b> intendedExposure</b> : </p> <ul> <li> <a name="NCT05503693-drug------ap303-50-g"> </a> </li> <li> <a name="NCT05503693-drug------ap303-150-g"> </a> </li> <li> <a name="NCT05503693-drug------ap303-300-g"> </a> </li> <li> <a name="NCT05503693-drug------ap303-600-g"> </a> </li> </ul> <blockquote> <p/>  <p> <a name="NCT05503693-drug------ap303-50-g"> </a> </p> <p> <b> name</b> : NCT05503693_drug______ap303_50_g</p> <p> <b> title</b> : AP303 50 μg</p> <p> <b> status</b> : active</p> <p> <b> description</b> : AP303 tablet</p> <h3> UseContexts</h3> <table class="grid"><tr> <td style="display: none">-</td> <td> <b> Code</b> </td> <td> <b> Value[x]</b> </td> </tr> <tr> <td style="display: none">*</td> <td> Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType
                 = 'interventionType', stated as 'Intervention Type for CT.gov')</td> <td> DRUG <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </td> </tr> </table> </blockquote> <blockquote> <p/>  <p> <a name="NCT05503693-drug------ap303-150-g"> </a> </p> <p> <b> name</b> : NCT05503693_drug______ap303_150_g</p> <p> <b> title</b> : AP303 150 μg</p> <p> <b> status</b> : active</p> <p> <b> description</b> : AP303 tablet</p> <h3> UseContexts</h3> <table class="grid"><tr> <td style="display: none">-</td> <td> <b> Code</b> </td> <td> <b> Value[x]</b> </td> </tr> <tr> <td style="display: none">*</td> <td> Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType
                 = 'interventionType', stated as 'Intervention Type for CT.gov')</td> <td> DRUG <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </td> </tr> </table> </blockquote> <blockquote> <p/>  <p> <a name="NCT05503693-drug------ap303-300-g"> </a> </p> <p> <b> name</b> : NCT05503693_drug______ap303_300_g</p> <p> <b> title</b> : AP303 300 μg</p> <p> <b> status</b> : active</p> <p> <b> description</b> : AP303 tablet</p> <h3> UseContexts</h3> <table class="grid"><tr> <td style="display: none">-</td> <td> <b> Code</b> </td> <td> <b> Value[x]</b> </td> </tr> <tr> <td style="display: none">*</td> <td> Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType
                 = 'interventionType', stated as 'Intervention Type for CT.gov')</td> <td> DRUG <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </td> </tr> </table> </blockquote> <blockquote> <p/>  <p> <a name="NCT05503693-drug------ap303-600-g"> </a> </p> <p> <b> name</b> : NCT05503693_drug______ap303_600_g</p> <p> <b> title</b> : AP303 600 μg</p> <p> <b> status</b> : active</p> <p> <b> description</b> : AP303 tablet</p> <h3> UseContexts</h3> <table class="grid"><tr> <td style="display: none">-</td> <td> <b> Code</b> </td> <td> <b> Value[x]</b> </td> </tr> <tr> <td style="display: none">*</td> <td> Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType
                 = 'interventionType', stated as 'Intervention Type for CT.gov')</td> <td> DRUG <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </td> </tr> </table> </blockquote> </blockquote> <blockquote> <p> <b> comparisonGroup</b> </p> <p> <b> linkId</b> : placebo</p> <p> <b> name</b> : Placebo</p> <p> <b> type</b> : Placebo Comparator <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </p> <p> <b> description</b> : Placebo</p> <p> <b> intendedExposure</b> : </p> <ul> <li> <a name="NCT05503693-drug------placebo-50-g"> </a> </li> <li> <a name="NCT05503693-drug------placebo-150-g"> </a> </li> <li> <a name="NCT05503693-drug------placebo-300-g"> </a> </li> <li> <a name="NCT05503693-drug------placebo-600-g"> </a> </li> </ul> <blockquote> <p/>  <p> <a name="NCT05503693-drug------placebo-50-g"> </a> </p> <p> <b> name</b> : NCT05503693_drug______placebo_50_g</p> <p> <b> title</b> : Placebo 50 μg</p> <p> <b> status</b> : active</p> <p> <b> description</b> : Placebo tablet</p> <h3> UseContexts</h3> <table class="grid"><tr> <td style="display: none">-</td> <td> <b> Code</b> </td> <td> <b> Value[x]</b> </td> </tr> <tr> <td style="display: none">*</td> <td> Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType
                 = 'interventionType', stated as 'Intervention Type for CT.gov')</td> <td> DRUG <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </td> </tr> </table> </blockquote> <blockquote> <p/>  <p> <a name="NCT05503693-drug------placebo-150-g"> </a> </p> <p> <b> name</b> : NCT05503693_drug______placebo_150_g</p> <p> <b> title</b> : Placebo 150 μg</p> <p> <b> status</b> : active</p> <p> <b> description</b> : Placebo tablet</p> <h3> UseContexts</h3> <table class="grid"><tr> <td style="display: none">-</td> <td> <b> Code</b> </td> <td> <b> Value[x]</b> </td> </tr> <tr> <td style="display: none">*</td> <td> Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType
                 = 'interventionType', stated as 'Intervention Type for CT.gov')</td> <td> DRUG <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </td> </tr> </table> </blockquote> <blockquote> <p/>  <p> <a name="NCT05503693-drug------placebo-300-g"> </a> </p> <p> <b> name</b> : NCT05503693_drug______placebo_300_g</p> <p> <b> title</b> : Placebo 300 μg</p> <p> <b> status</b> : active</p> <p> <b> description</b> : Placebo tablet</p> <h3> UseContexts</h3> <table class="grid"><tr> <td style="display: none">-</td> <td> <b> Code</b> </td> <td> <b> Value[x]</b> </td> </tr> <tr> <td style="display: none">*</td> <td> Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType
                 = 'interventionType', stated as 'Intervention Type for CT.gov')</td> <td> DRUG <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </td> </tr> </table> </blockquote> <blockquote> <p/>  <p> <a name="NCT05503693-drug------placebo-600-g"> </a> </p> <p> <b> name</b> : NCT05503693_drug______placebo_600_g</p> <p> <b> title</b> : Placebo 600 μg</p> <p> <b> status</b> : active</p> <p> <b> description</b> : Placebo tablet</p> <h3> UseContexts</h3> <table class="grid"><tr> <td style="display: none">-</td> <td> <b> Code</b> </td> <td> <b> Value[x]</b> </td> </tr> <tr> <td style="display: none">*</td> <td> Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType
                 = 'interventionType', stated as 'Intervention Type for CT.gov')</td> <td> DRUG <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span> </td> </tr> </table> </blockquote> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Single Dose and Food Effect Safety Outcome Measures</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign
           changes</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-0</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Multiple Dose Safety Outcome Measures</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : Incidence and severity of AEs, laboratory, ECG, and vital sign changes.</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-1</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Cmax after single dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after single dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-2</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Tmax after single dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after single dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-3</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : AUC0-last after single dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after single dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-4</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : AUC0-inf after single dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after single dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-5</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : t1/2 after single dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after single dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-6</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : CL/F after single dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after single dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-7</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Ae and CLR (if warranted) after single dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after single dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-8</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : V/F after single dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after single dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-9</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Cmax after multiple dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after multiple dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-10</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Tmax after multiple dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after multiple dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-11</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : AUC0-τ after multiple dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after multiple dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-12</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Cav after multiple dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after multiple dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-13</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : t1/2 after multiple dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after multiple dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-14</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Rac after multiple dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after multiple dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-15</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Ae and CLR (if warranted) after multiple dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after multiple dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-16</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : V/F after multiple dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after multiple dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-17</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Ctrough after multiple dose</p> <p> <b> type</b> : Primary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #primary)</span> </p> <p> <b> description</b> : PK characteristics after multiple dose</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-primaryOutcome-18</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Effect of Food on the single dose Cmax</p> <p> <b> type</b> : Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #secondary)</span> </p> <p> <b> description</b> : Effect of food on the single dose PK</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-secondaryOutcome-0</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Effect of Food on the single dose Tmax</p> <p> <b> type</b> : Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #secondary)</span> </p> <p> <b> description</b> : Effect of food on the single dose PK</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-secondaryOutcome-1</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Effect of Food on the single dose AUC0-last</p> <p> <b> type</b> : Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #secondary)</span> </p> <p> <b> description</b> : Effect of food on the single dose PK</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-secondaryOutcome-2</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Effect of Food on the single dose AUC0-inf</p> <p> <b> type</b> : Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #secondary)</span> </p> <p> <b> description</b> : Effect of food on the single dose PK</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-secondaryOutcome-3</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Effect of Food on the single dose t1/2</p> <p> <b> type</b> : Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #secondary)</span> </p> <p> <b> description</b> : Effect of food on the single dose PK</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-secondaryOutcome-4</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Effect of Food on the single dose CL/F</p> <p> <b> type</b> : Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #secondary)</span> </p> <p> <b> description</b> : Effect of food on the single dose PK</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-secondaryOutcome-5</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Effect of Food on the single dose Ae and CLR (if warranted)</p> <p> <b> type</b> : Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #secondary)</span> </p> <p> <b> description</b> : Effect of food on the single dose PK</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-secondaryOutcome-6</span> </p> </blockquote> <blockquote> <p> <b> outcomeMeasure</b> </p> <p> <b> name</b> : Effect of Food on the single dose V/F</p> <p> <b> type</b> : Secondary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.4.0/CodeSystem-research-study-objective-type.html">ResearchStudyObjectiveType</a> #secondary)</span> </p> <p> <b> description</b> : Effect of food on the single dose PK</p> <p> <b> reference</b> : <span> FEvIR Linking Identifier: NCT05503693-secondaryOutcome-7</span> </p> </blockquote> </div> </text> <contained> 
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  </contained> 
  <contained> 
    <Practitioner> 
      <id value="NCT05503693-CentralContact-0"/> 
      <name> 
        <text value="Zhen LIU"/> 
      </name> 
      <telecom> 
        <system value="phone"/> 
        <value value="86 021-60836212"/> 
      </telecom> 
      <telecom> 
        <system value="email"/> 
        <value value="clinicaloperation@alebund.com"/> 
      </telecom> 
    </Practitioner> 
  </contained> 
  <contained> 
    <ResearchStudy> 
      <id value="NCT05503693-Location-0-ResearchStudy"/> 
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        <type value="ResearchStudy"/> 
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      <site> 
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      <progressStatus> 
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  </contained> 
  <contained> 
    <Location> 
      <id value="NCT05503693-Location-0"/> 
      <name value="Nucleus Network Pty Ltd"/> 
      <address> 
        <city value="Melbourne"/> 
        <state value="Victoria"/> 
        <postalCode value="3004"/> 
        <country value="Australia"/> 
      </address> 
      <position> 
        <longitude value="144.96332"/> 
        <latitude value="-37.814"/> 
      </position> 
    </Location> 
  </contained> 
  <url value="https://fevir.net/resources/ResearchStudy/112103"/> 
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    </type> 
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    <value value="112103"/> 
    <assigner> 
      <display value="Computable Publishing LLC"/> 
    </assigner> 
  </identifier> 
  <identifier> 
    <use value="official"/> 
    <system value="https://clinicaltrials.gov"/> 
    <value value="NCT05503693"/> 
  </identifier> 
  <identifier> 
    <value value="AP303-PK-01"/> 
    <assigner> 
      <display value="Alebund Pharmaceuticals"/> 
    </assigner> 
  </identifier> 
  <name value="NCT05503693_FHIR_Transform"/> 
  <title value="A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects"/> 
  <label> 
    <type> 
      <text value="Official Title"/> 
    </type> 
    <value value="A Single-center Randomized Double-blind Placebo-controlled Study to Investigate
     the Safety Tolerability and PK of SAD and MAD of AP303 Following Oral Administration
     and the Effect of Food on the PK of AP303 in Healthy Subjects"/> 
  </label> 
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      <url value="https://beta.clinicaltrials.gov/api/v2/studies/NCT05503693"/> 
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  <relatedArtifact> 
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    <display value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/> 
    <document> 
      <url value="https://fevir.net/resources/Project/29885"/> 
    </document> 
  </relatedArtifact> 
  <status value="active"/> 
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      <display value="Treatment"/> 
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  <phase> 
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      <code value="phase-1"/> 
      <display value="Phase 1"/> 
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  </phase> 
  <studyDesign> 
    <text value="Design Masking: Quadruple"/> 
  </studyDesign> 
  <studyDesign> 
    <text value="Design Who Masked: Participant"/> 
  </studyDesign> 
  <studyDesign> 
    <text value="Design Who Masked: Care Provider"/> 
  </studyDesign> 
  <studyDesign> 
    <text value="Design Who Masked: Investigator"/> 
  </studyDesign> 
  <studyDesign> 
    <text value="Design Who Masked: Outcomes Assessor"/> 
  </studyDesign> 
  <studyDesign> 
    <text value="Design Allocation: Randomized"/> 
  </studyDesign> 
  <studyDesign> 
    <text value="Design Intervention Model: Sequential Assignment"/> 
  </studyDesign> 
  <studyDesign> 
    <text value="CT.gov StudyType: INTERVENTIONAL"/> 
  </studyDesign> 
  <condition> 
    <text value="Healthy Subjects"/> 
  </condition> 
  <keyword> 
    <text value="Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects"/> 
  </keyword> 
  <descriptionSummary value="This is a single-center, randomized, double-blind, placebo-controlled, first-in-human
   study in which the safety, tolerability, and pharmacokinetics of orally administered
   AP303 will be assessed in healthy adult subjects."/> 
  <description value="The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase
   enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending
   doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A
   will receive AP303 under both fasted and fed conditions to investigate the effect
   of food."/> 
  <site> 
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    <type value="ResearchStudy"/> 
  </site> 
  <classifier> 
    <text value="Has Results: False"/> 
  </classifier> 
  <classifier> 
    <text value="Oversight Classifier: oversightHasDmc Yes"/> 
  </classifier> 
  <classifier> 
    <text value="Oversight Classifier: isFdaRegulatedDrug No"/> 
  </classifier> 
  <classifier> 
    <text value="Oversight Classifier: isFdaRegulatedDevice No"/> 
  </classifier> 
  <associatedParty> 
    <name value="Alebund Pharmaceuticals"/> 
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        <code value="sponsor"/> 
        <display value="Sponsor"/> 
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    <classifier> 
      <text value="INDUSTRY"/> 
    </classifier> 
  </associatedParty> 
  <associatedParty> 
    <name value="Alebund Pty Ltd"/> 
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        <code value="lead-sponsor"/> 
        <display value="lead-sponsor"/> 
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    <classifier> 
      <text value="INDUSTRY"/> 
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  </associatedParty> 
  <associatedParty> 
    <name value="Zhen LIU"/> 
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        <code value="recruitment-contact"/> 
        <display value="recruitment-contact"/> 
      </coding> 
    </role> 
    <classifier> 
      <text value="Contact"/> 
    </classifier> 
    <party> 
      <reference value="#NCT05503693-CentralContact-0"/> 
      <type value="Practitioner"/> 
    </party> 
  </associatedParty> 
  <associatedParty> 
    <name value="Sam Francis, Doctor"/> 
    <role> 
      <text value="Principal Investigator"/> 
    </role> 
    <party> 
      <display value="Nucleus Network"/> 
    </party> 
  </associatedParty> 
  <progressStatus> 
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        <system value="http://hl7.org/fhir/research-study-status"/> 
        <code value="recruiting"/> 
        <display value="Recruiting"/> 
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    </state> 
  </progressStatus> 
  <progressStatus> 
    <state> 
      <coding> 
        <system value="http://hl7.org/fhir/research-study-status"/> 
        <code value="overall-study"/> 
        <display value="Overall Study"/> 
      </coding> 
    </state> 
    <actual value="false"/> 
    <period> 
      <start value="2022-12-06"/> 
      <end value="2023-06"/> 
    </period> 
  </progressStatus> 
  <recruitment> 
    <targetNumber value="62"/> 
    <eligibility> 
      <reference value="https://fevir.net/resources/EvidenceVariable/112075"/> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693 Eligibility Criteria"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </eligibility> 
  </recruitment> 
  <comparisonGroup> 
    <linkId value="ap303"/> 
    <name value="AP303"/> 
    <type> 
      <text value="Experimental"/> 
    </type> 
    <description value="AP303"/> 
    <intendedExposure> 
      <reference value="#NCT05503693-drug------ap303-50-g"/> 
      <type value="EvidenceVariable"/> 
      <display value="Drug: AP303 50 μg"/> 
    </intendedExposure> 
    <intendedExposure> 
      <reference value="#NCT05503693-drug------ap303-150-g"/> 
      <type value="EvidenceVariable"/> 
      <display value="Drug: AP303 150 μg"/> 
    </intendedExposure> 
    <intendedExposure> 
      <reference value="#NCT05503693-drug------ap303-300-g"/> 
      <type value="EvidenceVariable"/> 
      <display value="Drug: AP303 300 μg"/> 
    </intendedExposure> 
    <intendedExposure> 
      <reference value="#NCT05503693-drug------ap303-600-g"/> 
      <type value="EvidenceVariable"/> 
      <display value="Drug: AP303 600 μg"/> 
    </intendedExposure> 
  </comparisonGroup> 
  <comparisonGroup> 
    <linkId value="placebo"/> 
    <name value="Placebo"/> 
    <type> 
      <text value="Placebo Comparator"/> 
    </type> 
    <description value="Placebo"/> 
    <intendedExposure> 
      <reference value="#NCT05503693-drug------placebo-50-g"/> 
      <type value="EvidenceVariable"/> 
      <display value="Drug: Placebo 50 μg"/> 
    </intendedExposure> 
    <intendedExposure> 
      <reference value="#NCT05503693-drug------placebo-150-g"/> 
      <type value="EvidenceVariable"/> 
      <display value="Drug: Placebo 150 μg"/> 
    </intendedExposure> 
    <intendedExposure> 
      <reference value="#NCT05503693-drug------placebo-300-g"/> 
      <type value="EvidenceVariable"/> 
      <display value="Drug: Placebo 300 μg"/> 
    </intendedExposure> 
    <intendedExposure> 
      <reference value="#NCT05503693-drug------placebo-600-g"/> 
      <type value="EvidenceVariable"/> 
      <display value="Drug: Placebo 600 μg"/> 
    </intendedExposure> 
  </comparisonGroup> 
  <outcomeMeasure> 
    <name value="Single Dose and Food Effect Safety Outcome Measures"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign
     changes"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-0"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Multiple Dose Safety Outcome Measures"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="Incidence and severity of AEs, laboratory, ECG, and vital sign changes."/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-1"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Cmax after single dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after single dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-2"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Tmax after single dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after single dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-3"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="AUC0-last after single dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after single dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-4"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="AUC0-inf after single dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after single dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-5"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="t1/2 after single dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after single dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-6"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="CL/F after single dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after single dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-7"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Ae and CLR (if warranted) after single dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after single dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-8"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="V/F after single dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after single dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-9"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Cmax after multiple dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after multiple dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-10"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Tmax after multiple dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after multiple dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-11"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="AUC0-τ after multiple dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after multiple dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-12"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Cav after multiple dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after multiple dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-13"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="t1/2 after multiple dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after multiple dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-14"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Rac after multiple dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after multiple dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-15"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Ae and CLR (if warranted) after multiple dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after multiple dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-16"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="V/F after multiple dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after multiple dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-17"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Ctrough after multiple dose"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="primary"/> 
        <display value="Primary"/> 
      </coding> 
    </type> 
    <description value="PK characteristics after multiple dose"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-primaryOutcome-18"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Effect of Food on the single dose Cmax"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="secondary"/> 
        <display value="Secondary"/> 
      </coding> 
    </type> 
    <description value="Effect of food on the single dose PK"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-secondaryOutcome-0"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Effect of Food on the single dose Tmax"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="secondary"/> 
        <display value="Secondary"/> 
      </coding> 
    </type> 
    <description value="Effect of food on the single dose PK"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-secondaryOutcome-1"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Effect of Food on the single dose AUC0-last"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="secondary"/> 
        <display value="Secondary"/> 
      </coding> 
    </type> 
    <description value="Effect of food on the single dose PK"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-secondaryOutcome-2"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Effect of Food on the single dose AUC0-inf"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="secondary"/> 
        <display value="Secondary"/> 
      </coding> 
    </type> 
    <description value="Effect of food on the single dose PK"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-secondaryOutcome-3"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Effect of Food on the single dose t1/2"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="secondary"/> 
        <display value="Secondary"/> 
      </coding> 
    </type> 
    <description value="Effect of food on the single dose PK"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-secondaryOutcome-4"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Effect of Food on the single dose CL/F"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="secondary"/> 
        <display value="Secondary"/> 
      </coding> 
    </type> 
    <description value="Effect of food on the single dose PK"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-secondaryOutcome-5"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Effect of Food on the single dose Ae and CLR (if warranted)"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="secondary"/> 
        <display value="Secondary"/> 
      </coding> 
    </type> 
    <description value="Effect of food on the single dose PK"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-secondaryOutcome-6"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
  <outcomeMeasure> 
    <name value="Effect of Food on the single dose V/F"/> 
    <type> 
      <coding> 
        <system value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/> 
        <code value="secondary"/> 
        <display value="Secondary"/> 
      </coding> 
    </type> 
    <description value="Effect of food on the single dose PK"/> 
    <reference> 
      <type value="EvidenceVariable"/> 
      <identifier> 
        <type> 
          <text value="FEvIR Linking Identifier"/> 
        </type> 
        <system value="https://fevir.net/FLI"/> 
        <value value="NCT05503693-secondaryOutcome-7"/> 
        <assigner> 
          <display value="Computable Publishing LLC"/> 
        </assigner> 
      </identifier> 
    </reference> 
  </outcomeMeasure> 
</ResearchStudy> 

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.