R6 Ballot (1st Draft)
AdministrationThis page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions 
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: 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
| Type | Value |
| 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.
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 ()
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
| TargetNumber | Eligibility |
| 62 | https://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
Code Value[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
Code Value[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
Code Value[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
Code Value[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
Code Value[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
Code Value[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
Code Value[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
Code Value[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.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot1 generated on Mon, Dec 18, 2023 15:18+1100.
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