Researchstudy-example-ctgov-study-record

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

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 example-ctgov-study-record

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

identifier: FEvIR Object Identifier/https://fevir.net/FOI/112103, https://clinicaltrials.gov/NCT05503693 (use: official, ), AP303-PK-01

name: NCT05503693_FHIR_Transform

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

Labels

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
Documents

- Url

* https://clinicaltrials.gov/api/v2/studies/NCT05503693?format=json

relatedArtifact
type: transformed-with
display: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter
Documents

- Url

* https://fevir.net/resources/Project/29885

status: active

primaryPurposeType: Treatment

phase: Phase 1

studyDesign: Design Masking: Quadruple, Participant, Care Provider, Investigator, Outcomes Assessor, Randomized, Sequential Assignment, 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: Location Nucleus Network Pty Ltd

classifier: Has Results: False, Oversight Classifier: oversightHasDmc True, Oversight Classifier: isFdaRegulatedDrug False, Oversight Classifier: isFdaRegulatedDevice False

associatedParty
name: Alebund Pharmaceuticals
role: sponsor
classifier: INDUSTRY

associatedParty
name: Alebund Pty Ltd
role: lead-sponsor
classifier: INDUSTRY

associatedParty
name: Sam Francis, Doctor
role: primary-investigator
party: Nucleus Network

progressStatus
state: Completed

progressStatus
state: Overall study
actual: true
period: 2022-12-06 --> 2023-07-21

Recruitments

ActualNumber

Eligibility

comparisonGroup
eligibility: AP303

comparisonGroup
eligibility: Placebo

objective
outcomeMeasure
name: Single Dose and Food Effect Safety Outcome Measures
type: Primary
description:

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

endpoint: ??
outcomeMeasure
name: Multiple Dose Safety Outcome Measures
type: Primary
description:

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

endpoint: ??
outcomeMeasure
name: Cmax after single dose
type: Primary
description:

PK characteristics after single dose

endpoint: ??
outcomeMeasure
name: Tmax after single dose
type: Primary
description:

PK characteristics after single dose

endpoint: ??
outcomeMeasure
name: AUC0-last after single dose
type: Primary
description:

PK characteristics after single dose

endpoint: ??
outcomeMeasure
name: AUC0-inf after single dose
type: Primary
description:

PK characteristics after single dose

endpoint: ??
outcomeMeasure
name: t1/2 after single dose
type: Primary
description:

PK characteristics after single dose

endpoint: ??
outcomeMeasure
name: CL/F after single dose
type: Primary
description:

PK characteristics after single dose

endpoint: ??
outcomeMeasure
name: Ae and CLR (if warranted) after single dose
type: Primary
description:

PK characteristics after single dose

endpoint: ??
outcomeMeasure
name: V/F after single dose
type: Primary
description:

PK characteristics after single dose

endpoint: ??
outcomeMeasure
name: Cmax after multiple dose
type: Primary
description:

PK characteristics after multiple dose

endpoint: ??
outcomeMeasure
name: Tmax after multiple dose
type: Primary
description:

PK characteristics after multiple dose

endpoint: ??
outcomeMeasure
name: AUC0-τ after multiple dose
type: Primary
description:

PK characteristics after multiple dose

endpoint: ??
outcomeMeasure
name: Cav after multiple dose
type: Primary
description:

PK characteristics after multiple dose

endpoint: ??
outcomeMeasure
name: t1/2 after multiple dose
type: Primary
description:

PK characteristics after multiple dose

endpoint: ??
outcomeMeasure
name: Rac after multiple dose
type: Primary
description:

PK characteristics after multiple dose

endpoint: ??
outcomeMeasure
name: Ae and CLR (if warranted) after multiple dose
type: Primary
description:

PK characteristics after multiple dose

endpoint: ??
outcomeMeasure
name: V/F after multiple dose
type: Primary
description:

PK characteristics after multiple dose

endpoint: ??
outcomeMeasure
name: Ctrough after multiple dose
type: Primary
description:

PK characteristics after multiple dose

endpoint: ??
outcomeMeasure
name: Effect of Food on the single dose Cmax
type: Secondary
description:

Effect of food on the single dose PK

endpoint: ??
outcomeMeasure
name: Effect of Food on the single dose Tmax
type: Secondary
description:

Effect of food on the single dose PK

endpoint: ??
outcomeMeasure
name: Effect of Food on the single dose AUC0-last
type: Secondary
description:

Effect of food on the single dose PK

endpoint: ??
outcomeMeasure
name: Effect of Food on the single dose AUC0-inf
type: Secondary
description:

Effect of food on the single dose PK

endpoint: ??
outcomeMeasure
name: Effect of Food on the single dose t1/2
type: Secondary
description:

Effect of food on the single dose PK

endpoint: ??
outcomeMeasure
name: Effect of Food on the single dose CL/F
type: Secondary
description:

Effect of food on the single dose PK

endpoint: ??
outcomeMeasure
name: Effect of Food on the single dose Ae and CLR (if warranted)
type: Secondary
description:

Effect of food on the single dose PK

endpoint: ??
outcomeMeasure
name: Effect of Food on the single dose V/F
type: Secondary
description:

Effect of food on the single dose PK

endpoint: ??

Generated Narrative: EvidenceVariable #NCT05503693-drug------ap303-50-g

name: NCT05503693_drug______ap303_50_g
title: AP303 50 μg
status: active
description:

AP303 tablet

UseContexts

- Code Value[x]

* study-data-structure#enum-InterventionType interventionType: Intervention Type for ClinicalTrials.gov DRUG

Generated Narrative: EvidenceVariable #NCT05503693-drug------ap303-150-g

name: NCT05503693_drug______ap303_150_g
title: AP303 150 μg
status: active
description:

AP303 tablet

UseContexts

- Code Value[x]

* study-data-structure#enum-InterventionType interventionType: Intervention Type for ClinicalTrials.gov DRUG

Generated Narrative: EvidenceVariable #NCT05503693-drug------ap303-300-g

name: NCT05503693_drug______ap303_300_g
title: AP303 300 μg
status: active
description:

AP303 tablet

UseContexts

- Code Value[x]

* study-data-structure#enum-InterventionType interventionType: Intervention Type for ClinicalTrials.gov DRUG

Generated Narrative: EvidenceVariable #NCT05503693-drug------ap303-600-g

name: NCT05503693_drug______ap303_600_g
title: AP303 600 μg
status: active
description:

AP303 tablet

UseContexts

- Code Value[x]

* study-data-structure#enum-InterventionType interventionType: Intervention Type for ClinicalTrials.gov DRUG

Generated Narrative: EvidenceVariable #NCT05503693-drug------placebo-50-g

name: NCT05503693_drug______placebo_50_g
title: Placebo 50 μg
status: active
description:

Placebo tablet

UseContexts

- Code Value[x]

* study-data-structure#enum-InterventionType interventionType: Intervention Type for ClinicalTrials.gov DRUG

Generated Narrative: EvidenceVariable #NCT05503693-drug------placebo-150-g

name: NCT05503693_drug______placebo_150_g
title: Placebo 150 μg
status: active
description:

Placebo tablet

UseContexts

- Code Value[x]

* study-data-structure#enum-InterventionType interventionType: Intervention Type for ClinicalTrials.gov DRUG

Generated Narrative: EvidenceVariable #NCT05503693-drug------placebo-300-g

name: NCT05503693_drug______placebo_300_g
title: Placebo 300 μg
status: active
description:

Placebo tablet

UseContexts

- Code Value[x]

* study-data-structure#enum-InterventionType interventionType: Intervention Type for ClinicalTrials.gov DRUG

Generated Narrative: EvidenceVariable #NCT05503693-drug------placebo-600-g

name: NCT05503693_drug______placebo_600_g
title: Placebo 600 μg
status: active
description:

Placebo tablet

UseContexts

- Code Value[x]

* study-data-structure#enum-InterventionType interventionType: Intervention Type for ClinicalTrials.gov DRUG

Generated Narrative: Group #NCT05503693-comparison-group-0

identifier: FEvIR Linking Identifier/NCT05503693-comparison-group-0
title: NCT05503693 Comparison Group: AP303
status: active
description:

AP303

UseContexts

- Code Value[x]

* study-data-structure ArmGroupType: Arm Group Type Experimental
membership: conceptual
combinationMethod: all-of
characteristic
code: Exposed to
value: Drug: AP303 50 μg
exclude: false
characteristic
code: Exposed to
value: Drug: AP303 150 μg
exclude: false
characteristic
code: Exposed to
value: Drug: AP303 300 μg
exclude: false
characteristic
code: Exposed to
value: Drug: AP303 600 μg
exclude: false

Generated Narrative: Group #NCT05503693-comparison-group-1

identifier: FEvIR Linking Identifier/NCT05503693-comparison-group-1
title: NCT05503693 Comparison Group: Placebo
status: active
description:

Placebo

UseContexts

- Code Value[x]

* study-data-structure ArmGroupType: Arm Group Type Placebo Comparator
membership: conceptual
combinationMethod: all-of
characteristic
code: Exposed to
value: Drug: Placebo 50 μg
exclude: false
characteristic
code: Exposed to
value: Drug: Placebo 150 μg
exclude: false
characteristic
code: Exposed to
value: Drug: Placebo 300 μg
exclude: false
characteristic
code: Exposed to
value: Drug: Placebo 600 μg
exclude: false

Generated Narrative: Location #NCT05503693-Location-0

name: Nucleus Network Pty Ltd
address: Melbourne Victoria 3004 Australia
Positions

- Longitude Latitude

* 144.96332 -37.814

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.