example-ctgov-study-record
type: ResearchStudy
node role: treeRoot
id:
  v: example-ctgov-study-record
contained: EvidenceVariable
  id:
    v: NCT05503693-drug------ap303-50-g
  name:
    v: NCT05503693_drug______ap303_50_g
  title:
    v: AP303 50 μg
  status:
    v: active
  description:
    v: AP303 tablet
  use context:
    code:
      system:
        v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType
        l: enum-InterventionType
      code:
        v: interventionType
      display:
        v: Intervention Type for ClinicalTrials.gov
    value: CodeableConcept
      text:
        v: DRUG
contained: EvidenceVariable
  id:
    v: NCT05503693-drug------ap303-150-g
  name:
    v: NCT05503693_drug______ap303_150_g
  title:
    v: AP303 150 μg
  status:
    v: active
  description:
    v: AP303 tablet
  use context:
    code:
      system:
        v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType
        l: enum-InterventionType
      code:
        v: interventionType
      display:
        v: Intervention Type for ClinicalTrials.gov
    value: CodeableConcept
      text:
        v: DRUG
contained: EvidenceVariable
  id:
    v: NCT05503693-drug------ap303-300-g
  name:
    v: NCT05503693_drug______ap303_300_g
  title:
    v: AP303 300 μg
  status:
    v: active
  description:
    v: AP303 tablet
  use context:
    code:
      system:
        v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType
        l: enum-InterventionType
      code:
        v: interventionType
      display:
        v: Intervention Type for ClinicalTrials.gov
    value: CodeableConcept
      text:
        v: DRUG
contained: EvidenceVariable
  id:
    v: NCT05503693-drug------ap303-600-g
  name:
    v: NCT05503693_drug______ap303_600_g
  title:
    v: AP303 600 μg
  status:
    v: active
  description:
    v: AP303 tablet
  use context:
    code:
      system:
        v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType
        l: enum-InterventionType
      code:
        v: interventionType
      display:
        v: Intervention Type for ClinicalTrials.gov
    value: CodeableConcept
      text:
        v: DRUG
contained: EvidenceVariable
  id:
    v: NCT05503693-drug------placebo-50-g
  name:
    v: NCT05503693_drug______placebo_50_g
  title:
    v: Placebo 50 μg
  status:
    v: active
  description:
    v: Placebo tablet
  use context:
    code:
      system:
        v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType
        l: enum-InterventionType
      code:
        v: interventionType
      display:
        v: Intervention Type for ClinicalTrials.gov
    value: CodeableConcept
      text:
        v: DRUG
contained: EvidenceVariable
  id:
    v: NCT05503693-drug------placebo-150-g
  name:
    v: NCT05503693_drug______placebo_150_g
  title:
    v: Placebo 150 μg
  status:
    v: active
  description:
    v: Placebo tablet
  use context:
    code:
      system:
        v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType
        l: enum-InterventionType
      code:
        v: interventionType
      display:
        v: Intervention Type for ClinicalTrials.gov
    value: CodeableConcept
      text:
        v: DRUG
contained: EvidenceVariable
  id:
    v: NCT05503693-drug------placebo-300-g
  name:
    v: NCT05503693_drug______placebo_300_g
  title:
    v: Placebo 300 μg
  status:
    v: active
  description:
    v: Placebo tablet
  use context:
    code:
      system:
        v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType
        l: enum-InterventionType
      code:
        v: interventionType
      display:
        v: Intervention Type for ClinicalTrials.gov
    value: CodeableConcept
      text:
        v: DRUG
contained: EvidenceVariable
  id:
    v: NCT05503693-drug------placebo-600-g
  name:
    v: NCT05503693_drug______placebo_600_g
  title:
    v: Placebo 600 μg
  status:
    v: active
  description:
    v: Placebo tablet
  use context:
    code:
      system:
        v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType
        l: enum-InterventionType
      code:
        v: interventionType
      display:
        v: Intervention Type for ClinicalTrials.gov
    value: CodeableConcept
      text:
        v: DRUG
contained: Group
  id:
    v: NCT05503693-comparison-group-0
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT05503693-comparison-group-0
    assigner:
      display:
        v: Computable Publishing LLC
contained: Location

v: NCT05503693 Comparison Group: AP303

v: active

v: AP303

code:
  system:
    v: https://clinicaltrials.gov/data-about-studies/study-data-structure
    l: study-data-structure
  code:
    v: ArmGroupType
  display:
    v: Arm Group Type
value: CodeableConcept
  coding:
    system:
      v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-ArmGroupType
      l: enum-ArmGroupType
    code:
      v: EXPERIMENTAL
    display:
      v: Experimental

v: conceptual

v: all-of

code:
  text:
    v: Exposed to
value: Reference
  l: NCT05503693-drug------ap303-50-g
  reference:
    v: #NCT05503693-drug------ap303-50-g
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Drug: AP303 50 μg
exclude:
  v: false

code:
  text:
    v: Exposed to
value: Reference
  l: NCT05503693-drug------ap303-150-g
  reference:
    v: #NCT05503693-drug------ap303-150-g
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Drug: AP303 150 μg
exclude:
  v: false

code:
  text:
    v: Exposed to
value: Reference
  l: NCT05503693-drug------ap303-300-g
  reference:
    v: #NCT05503693-drug------ap303-300-g
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Drug: AP303 300 μg
exclude:
  v: false

code:
  text:
    v: Exposed to
value: Reference
  l: NCT05503693-drug------ap303-600-g
  reference:
    v: #NCT05503693-drug------ap303-600-g
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Drug: AP303 600 μg
exclude:
  v: false

Group
id:
  v: NCT05503693-comparison-group-1
identifier:
  type:
    text:
      v: FEvIR Linking Identifier
  system:
    v: https://fevir.net/FLI
    l: FLI
  value:
    v: NCT05503693-comparison-group-1
  assigner:
    display:
      v: Computable Publishing LLC
title:
  v: NCT05503693 Comparison Group: Placebo
status:
  v: active
description:
  v: Placebo
use context:
  code:
    system:
      v: https://clinicaltrials.gov/data-about-studies/study-data-structure
      l: study-data-structure
    code:
      v: ArmGroupType
    display:
      v: Arm Group Type
  value: CodeableConcept
    coding:
      system:
        v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-ArmGroupType
        l: enum-ArmGroupType
      code:
        v: PLACEBO_COMPARATOR
      display:
        v: Placebo Comparator
membership:
  v: conceptual
combination method:
  v: all-of
characteristic:
  code:
    text:
      v: Exposed to
  value: Reference
    l: NCT05503693-drug------placebo-50-g
    reference:
      v: #NCT05503693-drug------placebo-50-g
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Drug: Placebo 50 μg
  exclude:
    v: false
characteristic:
  code:
    text:
      v: Exposed to
  value: Reference
    l: NCT05503693-drug------placebo-150-g
    reference:
      v: #NCT05503693-drug------placebo-150-g
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Drug: Placebo 150 μg
  exclude:
    v: false
characteristic:
  code:
    text:
      v: Exposed to
  value: Reference
    l: NCT05503693-drug------placebo-300-g
    reference:
      v: #NCT05503693-drug------placebo-300-g
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Drug: Placebo 300 μg
  exclude:
    v: false
characteristic:
  code:
    text:
      v: Exposed to
  value: Reference
    l: NCT05503693-drug------placebo-600-g
    reference:
      v: #NCT05503693-drug------placebo-600-g
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Drug: Placebo 600 μg
  exclude:
    v: false

Location
id:
  v: NCT05503693-Location-0
name:
  v: Nucleus Network Pty Ltd
address:
  city:
    v: Melbourne
  state:
    v: Victoria
  postal code:
    v: 3004
  country:
    v: Australia
position:
  longitude:
    v: 144.96332
  latitude:
    v: -37.814

type:
  text:
    v: FEvIR Object Identifier
system:
  v: urn:ietf:rfc:3986
  l: 3986
value:
  v: https://fevir.net/FOI/112103
assigner:
  display:
    v: Computable Publishing LLC

use:
  v: official
system:
  v: https://clinicaltrials.gov
  l: clinicaltrials.gov
value:
  v: NCT05503693

value:
  v: AP303-PK-01
assigner:
  display:
    v: Alebund Pharmaceuticals

v: NCT05503693_FHIR_Transform

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

type:
  coding:
    system:
      v: http://hl7.org/fhir/title-type
      l: title-type
    code:
      v: official
    display:
      v: Official title
value:
  v: 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

type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/artifact-relationship-type
      l: artifact-relationship-type
    code:
      v: transforms
    display:
      v: Transforms
target: Uri
  v: https://clinicaltrials.gov/api/v2/studies/NCT05503693
  l: https://clinicaltrials.gov/api/v2/studies/NCT05503693

type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/artifact-relationship-type
      l: artifact-relationship-type
    code:
      v: transformed-with
    display:
      v: Transformed With
target: Attachment
  url:
    v: https://fevir.net/resources/Project/29885
    l: https://fevir.net/resources/Project/29885
  title:
    v: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter

v: active

coding:
  system:
    v: http://terminology.hl7.org/CodeSystem/research-study-purpose-type
    l: research-study-purpose-type
  code:
    v: treatment
  display:
    v: Treatment Study

coding:
  system:
    v: https://fevir.net/sevco
    l: sevco
  code:
    v: SEVCO:01030
  display:
    v: Phase 1 trial

text:
  v: Design Masking: Quadruple

coding:
  system:
    v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-WhoMasked
    l: enum-WhoMasked
  code:
    v: PARTICIPANT
  display:
    v: Participant
coding:
  system:
    v: https://fevir.net/sevco
    l: sevco
  code:
    v: SEVCO:01060
  display:
    v: Blinding of study participants

coding:
  system:
    v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-WhoMasked
    l: enum-WhoMasked
  code:
    v: CARE_PROVIDER
  display:
    v: Care Provider
coding:
  system:
    v: https://fevir.net/sevco
    l: sevco
  code:
    v: SEVCO:01061
  display:
    v: Blinding of intervention providers

coding:
  system:
    v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-WhoMasked
    l: enum-WhoMasked
  code:
    v: INVESTIGATOR
  display:
    v: Investigator
coding:
  system:
    v: https://fevir.net/sevco
    l: sevco
  code:
    v: SEVCO:01063
  display:
    v: Blinding of data analysts

coding:
  system:
    v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-WhoMasked
    l: enum-WhoMasked
  code:
    v: OUTCOMES_ASSESSOR
  display:
    v: Outcomes Assessor
coding:
  system:
    v: https://fevir.net/sevco
    l: sevco
  code:
    v: SEVCO:01062
  display:
    v: Blinding of outcome assessors

coding:
  system:
    v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-DesignAllocation
    l: enum-DesignAllocation
  code:
    v: RANDOMIZED
  display:
    v: Randomized
coding:
  system:
    v: https://fevir.net/sevco
    l: sevco
  code:
    v: SEVCO:01003
  display:
    v: randomized assignment

coding:
  system:
    v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionalAssignment
    l: enum-InterventionalAssignment
  code:
    v: SEQUENTIAL
  display:
    v: Sequential Assignment
coding:
  system:
    v: https://fevir.net/sevco
    l: sevco
  code:
    v: SEVCO:01025
  display:
    v: Single-arm crossover design

coding:
  system:
    v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-StudyType
    l: enum-StudyType
  code:
    v: INTERVENTIONAL
  display:
    v: Interventional
coding:
  system:
    v: https://fevir.net/sevco
    l: sevco
  code:
    v: SEVCO:01001
  display:
    v: interventional research

text:
  v: Healthy Subjects

text:
  v: Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects

v: 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.

v: 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.

l: NCT05503693-Location-0
reference:
  v: #NCT05503693-Location-0
type:
  v: Location
  l: Location

text:
  v: Has Results: False

text:
  v: Oversight Classifier: oversightHasDmc True

text:
  v: Oversight Classifier: isFdaRegulatedDrug False

text:
  v: Oversight Classifier: isFdaRegulatedDevice False

name:
  v: Alebund Pharmaceuticals
role:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-party-role
      l: research-study-party-role
    code:
      v: sponsor
    display:
      v: Sponsor
classifier:
  coding:
    system:
      v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-AgencyClass
      l: enum-AgencyClass
    code:
      v: INDUSTRY
    display:
      v: INDUSTRY

name:
  v: Alebund Pty Ltd
role:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-party-role
      l: research-study-party-role
    code:
      v: lead-sponsor
    display:
      v: Lead sponsor
classifier:
  coding:
    system:
      v: https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-AgencyClass
      l: enum-AgencyClass
    code:
      v: INDUSTRY
    display:
      v: INDUSTRY

name:
  v: Sam Francis, Doctor
role:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-party-role
      l: research-study-party-role
    code:
      v: primary-investigator
    display:
      v: Principal investigator
party:
  display:
    v: Nucleus Network

state:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-status
      l: research-study-status
    code:
      v: completed
    display:
      v: Completed

state:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-status
      l: research-study-status
    code:
      v: overall-study
    display:
      v: Overall study
actual:
  v: true
period:
  start:
    v: 2022-12-06
  end:
    v: 2023-07-21

actual number:
  v: 62
eligibility:
  l: http://hl7.org/fhir/Group/112075
  reference:
    v: Group/112075
  type:
    v: Group
    l: Group
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT05503693 Eligibility Criteria
    assigner:
      display:
        v: Computable Publishing LLC

eligibility:
  l: NCT05503693-comparison-group-0
  reference:
    v: #NCT05503693-comparison-group-0
  type:
    v: Group
    l: Group
  display:
    v: AP303

eligibility:
  l: NCT05503693-comparison-group-1
  reference:
    v: #NCT05503693-comparison-group-1
  type:
    v: Group
    l: Group
  display:
    v: Placebo

outcome measure:
  name:
    v: Single Dose and Food Effect Safety Outcome Measures
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: primary
      display:
        v: Primary
  description:
    v: Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign changes
  endpoint:
    l: http://hl7.org/fhir/EvidenceVariable/112076
    reference:
      v: EvidenceVariable/112076
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT05503693-primaryOutcome-0
outcome measure:
  name:
    v: Multiple Dose Safety Outcome Measures
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: primary
      display:
        v: Primary
  description:
    v: Incidence and severity of AEs, laboratory, ECG, and vital sign changes.
  endpoint:
    l: http://hl7.org/fhir/EvidenceVariable/112077
    reference:
      v: EvidenceVariable/112077
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT05503693-primaryOutcome-1
outcome measure:
  name:
    v: Cmax after single dose
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: primary
      display:
        v: Primary
  description:
    v: PK characteristics after single dose
  endpoint:
    l: http://hl7.org/fhir/EvidenceVariable/112078
    reference:
      v: EvidenceVariable/112078
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT05503693-primaryOutcome-2
outcome measure:
  name:
    v: Tmax after single dose
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: primary
      display:
        v: Primary
  description:
    v: PK characteristics after single dose
  endpoint:
    l: http://hl7.org/fhir/EvidenceVariable/112079
    reference:
      v: EvidenceVariable/112079
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT05503693-primaryOutcome-3
outcome measure:
  name:
    v: AUC0-last after single dose
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: primary
      display:
        v: Primary
  description:
    v: PK characteristics after single dose
  endpoint:
    l: http://hl7.org/fhir/EvidenceVariable/112080
    reference:
      v: EvidenceVariable/112080
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT05503693-primaryOutcome-4
outcome measure:
  name:
    v: AUC0-inf after single dose
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: primary
      display:
        v: Primary
  description:
    v: PK characteristics after single dose
  endpoint:
    l: http://hl7.org/fhir/EvidenceVariable/112081
    reference:
      v: EvidenceVariable/112081
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT05503693-primaryOutcome-5
outcome measure:
  name:
    v: t1/2 after single dose
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: primary
      display:
        v: Primary
  description:
    v: PK characteristics after single dose
  endpoint:
    l: http://hl7.org/fhir/EvidenceVariable/112082
    reference:
      v: EvidenceVariable/112082
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT05503693-primaryOutcome-6
outcome measure:
  name:
    v: CL/F after single dose
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: primary
      display:
        v: Primary

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

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name:
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