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| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Group |
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
| 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 |
relatesTo
type: transforms
target: https://clinicaltrials.gov/api/v2/studies/NCT05503693?format=json
relatesTo
type: transformed-with
target: null @ https://fevir.net/resources/Project/29885
status: active
primaryPurposeType: Treatment
phase: Phase 1 trial
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: Principal investigator
party: Nucleus Network
progressStatus
state: Completed
progressStatus
state: Overall study
actual: true
period: 2022-12-06 --> 2023-07-21
| ActualNumber | Eligibility |
| 62 | Group/112075 |
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: EvidenceVariable/112076
outcomeMeasure
name: Multiple Dose Safety Outcome Measures
type: Primary
description:
Incidence and severity of AEs, laboratory, ECG, and vital sign changes.
endpoint: EvidenceVariable/112077
outcomeMeasure
name: Cmax after single dose
type: Primary
description:
PK characteristics after single dose
endpoint: EvidenceVariable/112078
outcomeMeasure
name: Tmax after single dose
type: Primary
description:
PK characteristics after single dose
endpoint: EvidenceVariable/112079
outcomeMeasure
name: AUC0-last after single dose
type: Primary
description:
PK characteristics after single dose
endpoint: EvidenceVariable/112080
outcomeMeasure
name: AUC0-inf after single dose
type: Primary
description:
PK characteristics after single dose
endpoint: EvidenceVariable/112081
outcomeMeasure
name: t1/2 after single dose
type: Primary
description:
PK characteristics after single dose
endpoint: EvidenceVariable/112082
outcomeMeasure
name: CL/F after single dose
type: Primary
description:
PK characteristics after single dose
endpoint: EvidenceVariable/112083
outcomeMeasure
name: Ae and CLR (if warranted) after single dose
type: Primary
description:
PK characteristics after single dose
endpoint: EvidenceVariable/112084
outcomeMeasure
name: V/F after single dose
type: Primary
description:
PK characteristics after single dose
endpoint: EvidenceVariable/112085
outcomeMeasure
name: Cmax after multiple dose
type: Primary
description:
PK characteristics after multiple dose
endpoint: EvidenceVariable/112086
outcomeMeasure
name: Tmax after multiple dose
type: Primary
description:
PK characteristics after multiple dose
endpoint: EvidenceVariable/112087
outcomeMeasure
name: AUC0-τ after multiple dose
type: Primary
description:
PK characteristics after multiple dose
endpoint: EvidenceVariable/112088
outcomeMeasure
name: Cav after multiple dose
type: Primary
description:
PK characteristics after multiple dose
endpoint: EvidenceVariable/112089
outcomeMeasure
name: t1/2 after multiple dose
type: Primary
description:
PK characteristics after multiple dose
endpoint: EvidenceVariable/112090
outcomeMeasure
name: Rac after multiple dose
type: Primary
description:
PK characteristics after multiple dose
endpoint: EvidenceVariable/112091
outcomeMeasure
name: Ae and CLR (if warranted) after multiple dose
type: Primary
description:
PK characteristics after multiple dose
endpoint: EvidenceVariable/112092
outcomeMeasure
name: V/F after multiple dose
type: Primary
description:
PK characteristics after multiple dose
endpoint: EvidenceVariable/112093
outcomeMeasure
name: Ctrough after multiple dose
type: Primary
description:
PK characteristics after multiple dose
endpoint: EvidenceVariable/112094
outcomeMeasure
name: Effect of Food on the single dose Cmax
type: Secondary
description:
Effect of food on the single dose PK
endpoint: EvidenceVariable/112095
outcomeMeasure
name: Effect of Food on the single dose Tmax
type: Secondary
description:
Effect of food on the single dose PK
endpoint: EvidenceVariable/112096
outcomeMeasure
name: Effect of Food on the single dose AUC0-last
type: Secondary
description:
Effect of food on the single dose PK
endpoint: EvidenceVariable/112097
outcomeMeasure
name: Effect of Food on the single dose AUC0-inf
type: Secondary
description:
Effect of food on the single dose PK
endpoint: EvidenceVariable/112098
outcomeMeasure
name: Effect of Food on the single dose t1/2
type: Secondary
description:
Effect of food on the single dose PK
endpoint: EvidenceVariable/112099
outcomeMeasure
name: Effect of Food on the single dose CL/F
type: Secondary
description:
Effect of food on the single dose PK
endpoint: EvidenceVariable/112100
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: EvidenceVariable/112101
outcomeMeasure
name: Effect of Food on the single dose V/F
type: Secondary
description:
Effect of food on the single dose PK
endpoint: EvidenceVariable/112102
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.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot2 generated on Tue, Mar 18, 2025 14:04+0000.
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