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

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

This is the narrative for the resource. See also the XML, JSON or Turtle format. This example conforms to the profile ResearchStudy.


Generated Narrative: ResearchStudy

Resource ResearchStudy "example-ctgov-study-record"

url: https://fevir.net/resources/ResearchStudy/112103

identifier: FEvIR Object Identifier: 112103, id: NCT05503693 (use: OFFICIAL), id: AP303-PK-01

name: NCT05503693_FHIR_Transform

title: A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects

Labels

-TypeValue
*Official Title ()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

relatedArtifact

type: transforms

document

relatedArtifact

type: transformed-with

display: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter

document

status: active

primaryPurposeType: Treatment (ResearchStudyPrimaryPurposeType#treatment)

phase: Phase 1 (ResearchStudyPhase#phase-1)

studyDesign: Design Masking: Quadruple (), Design Who Masked: Participant (), Design Who Masked: Care Provider (), Design Who Masked: Investigator (), Design Who Masked: Outcomes Assessor (), Design Allocation: Randomized (), Design Intervention Model: Sequential Assignment (), CT.gov StudyType: INTERVENTIONAL ()

condition: Healthy Subjects ()

keyword: Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects ()

descriptionSummary: 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: 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:

partOf: #

status: active

site: #NCT05503693-Location-0

ProgressStatuses

-State
*Recruiting (Research Study Status#recruiting)

classifier: Has Results: False (), Oversight Classifier: oversightHasDmc Yes (), Oversight Classifier: isFdaRegulatedDrug No (), Oversight Classifier: isFdaRegulatedDevice No ()

associatedParty

name: Alebund Pharmaceuticals

role: Sponsor (Research Study Party Role#sponsor)

classifier: INDUSTRY ()

associatedParty

name: Alebund Pty Ltd

role: lead-sponsor (Research Study Party Role#lead-sponsor)

classifier: INDUSTRY ()

associatedParty

name: Zhen LIU

role: recruitment-contact (Research Study Party Role#recruitment-contact)

classifier: Contact ()

party:

name: Zhen LIU

telecom: ph: 86 021-60836212, clinicaloperation@alebund.com

associatedParty

name: Sam Francis, Doctor

role: Principal Investigator ()

party: : Nucleus Network

progressStatus

state: Recruiting (Research Study Status#recruiting)

progressStatus

state: Overall Study (Research Study Status#overall-study)

actual: false

period: 2022-12-06 --> 2023-06

Recruitments

-TargetNumberEligibility
*62https://fevir.net/resources/EvidenceVariable/112075

comparisonGroup

linkId: ap303

name: AP303

type: Experimental ()

description: AP303

intendedExposure:

name: NCT05503693_drug______ap303_50_g

title: AP303 50 μg

status: active

description: AP303 tablet

UseContexts

-CodeValue[x]
*Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')DRUG ()

name: NCT05503693_drug______ap303_150_g

title: AP303 150 μg

status: active

description: AP303 tablet

UseContexts

-CodeValue[x]
*Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')DRUG ()

name: NCT05503693_drug______ap303_300_g

title: AP303 300 μg

status: active

description: AP303 tablet

UseContexts

-CodeValue[x]
*Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')DRUG ()

name: NCT05503693_drug______ap303_600_g

title: AP303 600 μg

status: active

description: AP303 tablet

UseContexts

-CodeValue[x]
*Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')DRUG ()

comparisonGroup

linkId: placebo

name: Placebo

type: Placebo Comparator ()

description: Placebo

intendedExposure:

name: NCT05503693_drug______placebo_50_g

title: Placebo 50 μg

status: active

description: Placebo tablet

UseContexts

-CodeValue[x]
*Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')DRUG ()

name: NCT05503693_drug______placebo_150_g

title: Placebo 150 μg

status: active

description: Placebo tablet

UseContexts

-CodeValue[x]
*Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')DRUG ()

name: NCT05503693_drug______placebo_300_g

title: Placebo 300 μg

status: active

description: Placebo tablet

UseContexts

-CodeValue[x]
*Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')DRUG ()

name: NCT05503693_drug______placebo_600_g

title: Placebo 600 μg

status: active

description: Placebo tablet

UseContexts

-CodeValue[x]
*Intervention Type for CT.gov (Details: https://clinicaltrials.gov code interventionType = 'interventionType', stated as 'Intervention Type for CT.gov')DRUG ()

outcomeMeasure

name: Single Dose and Food Effect Safety Outcome Measures

type: Primary (ResearchStudyObjectiveType#primary)

description: Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign changes

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-0

outcomeMeasure

name: Multiple Dose Safety Outcome Measures

type: Primary (ResearchStudyObjectiveType#primary)

description: Incidence and severity of AEs, laboratory, ECG, and vital sign changes.

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-1

outcomeMeasure

name: Cmax after single dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after single dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-2

outcomeMeasure

name: Tmax after single dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after single dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-3

outcomeMeasure

name: AUC0-last after single dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after single dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-4

outcomeMeasure

name: AUC0-inf after single dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after single dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-5

outcomeMeasure

name: t1/2 after single dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after single dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-6

outcomeMeasure

name: CL/F after single dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after single dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-7

outcomeMeasure

name: Ae and CLR (if warranted) after single dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after single dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-8

outcomeMeasure

name: V/F after single dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after single dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-9

outcomeMeasure

name: Cmax after multiple dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after multiple dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-10

outcomeMeasure

name: Tmax after multiple dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after multiple dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-11

outcomeMeasure

name: AUC0-τ after multiple dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after multiple dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-12

outcomeMeasure

name: Cav after multiple dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after multiple dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-13

outcomeMeasure

name: t1/2 after multiple dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after multiple dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-14

outcomeMeasure

name: Rac after multiple dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after multiple dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-15

outcomeMeasure

name: Ae and CLR (if warranted) after multiple dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after multiple dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-16

outcomeMeasure

name: V/F after multiple dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after multiple dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-17

outcomeMeasure

name: Ctrough after multiple dose

type: Primary (ResearchStudyObjectiveType#primary)

description: PK characteristics after multiple dose

reference: FEvIR Linking Identifier: NCT05503693-primaryOutcome-18

outcomeMeasure

name: Effect of Food on the single dose Cmax

type: Secondary (ResearchStudyObjectiveType#secondary)

description: Effect of food on the single dose PK

reference: FEvIR Linking Identifier: NCT05503693-secondaryOutcome-0

outcomeMeasure

name: Effect of Food on the single dose Tmax

type: Secondary (ResearchStudyObjectiveType#secondary)

description: Effect of food on the single dose PK

reference: FEvIR Linking Identifier: NCT05503693-secondaryOutcome-1

outcomeMeasure

name: Effect of Food on the single dose AUC0-last

type: Secondary (ResearchStudyObjectiveType#secondary)

description: Effect of food on the single dose PK

reference: FEvIR Linking Identifier: NCT05503693-secondaryOutcome-2

outcomeMeasure

name: Effect of Food on the single dose AUC0-inf

type: Secondary (ResearchStudyObjectiveType#secondary)

description: Effect of food on the single dose PK

reference: FEvIR Linking Identifier: NCT05503693-secondaryOutcome-3

outcomeMeasure

name: Effect of Food on the single dose t1/2

type: Secondary (ResearchStudyObjectiveType#secondary)

description: Effect of food on the single dose PK

reference: FEvIR Linking Identifier: NCT05503693-secondaryOutcome-4

outcomeMeasure

name: Effect of Food on the single dose CL/F

type: Secondary (ResearchStudyObjectiveType#secondary)

description: Effect of food on the single dose PK

reference: FEvIR Linking Identifier: NCT05503693-secondaryOutcome-5

outcomeMeasure

name: Effect of Food on the single dose Ae and CLR (if warranted)

type: Secondary (ResearchStudyObjectiveType#secondary)

description: Effect of food on the single dose PK

reference: FEvIR Linking Identifier: NCT05503693-secondaryOutcome-6

outcomeMeasure

name: Effect of Food on the single dose V/F

type: Secondary (ResearchStudyObjectiveType#secondary)

description: Effect of food on the single dose PK

reference: FEvIR Linking Identifier: NCT05503693-secondaryOutcome-7


 

 

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.