A Study to Evaluate if AC-084 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects
2018년 7월 6일 업데이트: Idorsia Pharmaceuticals Ltd.
A Three-part Single-center, Phase 1 Study to Assess the Tolerability, Safety, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Ascending Single and Multiple Doses of AC-084 in Healthy Subjects and to Investigate the Pharmacokinetics of a Single Dose of AC-084 in Healthy CYP2C9 Poor Metabolizers
The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and well-tolerated when orally administered at single- and multiple-ascending dose to healthy adults
연구 개요
상세 설명
The study is designed in three parts, A, B and C
Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose
Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose
Part C: single-center, open-label, single dose in CYP2C9 poor metabolizers
연구 유형
중재적
등록 (실제)
56
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Leeds, 영국, LS2 9LH
- Covance Clinical Research Unit
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Signed informed consent in the local language prior to any study-mandated procedure
- Healthy male subjects for Part A, healthy male and female subjects for Part B and Part C aged between 18 and 55 years (inclusive) at screening
- No clinically significant findings on physical examination at screening
- Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at screening
- CYP2C9 poor metabolizers (Part C)
Exclusion Criteria:
- History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed)
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
- Treatment or substances known to induce CYP enzyme drug metabolism within 30 days prior to first study treatment administration
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
- Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of their excipients
- For Part A and Part B, CYP2C9 poor metabolizers enrolled in a cohort to be dosed with single or multiple dose of 500 mg or higher of ACT-774312 (confirmed by genotyping before enrollment)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: AC-084, single ascending dose (Part A)
AC-084 administered at different single dose levels in a sequential manner, and in a maximum of 7 dose levels starting from 1 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort).
Each dose level will be investigated in a new group of at least 8 healthy male subjects (6 on active drug and 2 on placebo)
|
Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
|
|
위약 비교기: Placebo,single ascending dose (Part A)
Matched placebo administered as single ascending doses in parallel to AC-084
|
Placebo capsules matching AC-084 capsules
|
|
실험적: AC-084, multiple ascending dose (Part B)
AC-084 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels.
The starting dose will be between 1 and 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A. Each dose level will be investigated in a new group of at least 8 healthy male subjects (6 on active drug and 2 on placebo)
|
Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
|
|
위약 비교기: Placebo,multiple ascending dose (Part B)
Matched placebo administered as multiple ascending doses in parallel to AC-084
|
Placebo capsules matching AC-084 capsules
|
|
실험적: AC-084, single dose (Part C)
Up to 6 subjects in part C will receive AC-084 administered at a single dose (foreseen to be 100 mg)
|
Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of participants with adverse events (AEs) (Part A)
기간: From dosing until day 4
|
Treatment-emergent AEs and treatment-emergent serious AEs
|
From dosing until day 4
|
|
Number of participants with adverse events (AEs) (Part B)
기간: From dosing until day 8
|
Treatment-emergent AEs and treatment-emergent serious AEs
|
From dosing until day 8
|
|
Number of participants with adverse events (AEs) (Part C)
기간: From dosing until day 6
|
Treatment-emergent AEs and treatment-emergent serious AEs
|
From dosing until day 6
|
|
Incidence of safety events of interest (Part A)
기간: From dosing until day 4
|
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
|
From dosing until day 4
|
|
Incidence of safety events of interest (Part B)
기간: From dosing until day 8
|
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
|
From dosing until day 8
|
|
Incidence of safety events of interest (Part C)
기간: From dosing until day 6
|
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
|
From dosing until day 6
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maximum plasma concentration (Cmax) following single oral ascending doses (Part A)
기간: From dosing until day 4
|
Cmax is derived from the observed plasma concentration-time curves
|
From dosing until day 4
|
|
Maximum plasma concentration (Cmax) following single oral ascending doses (Part B)
기간: From dosing until day 8
|
Cmax is derived from the observed plasma concentration-time curves
|
From dosing until day 8
|
|
Maximum plasma concentration (Cmax) following single oral ascending doses (Part C)
기간: From dosing until day 6
|
Cmax is derived from the observed plasma concentration-time curves
|
From dosing until day 6
|
|
Time to reach Cmax (tmax) following single oral ascending doses (Part A)
기간: From dosing until day 4
|
Tmax is derived from the observed plasma concentration-time curves
|
From dosing until day 4
|
|
Time to reach Cmax (tmax) following single oral ascending doses (Part B)
기간: From dosing until day 8
|
Tmax is derived from the observed plasma concentration-time curves
|
From dosing until day 8
|
|
Time to reach Cmax (tmax) following single oral ascending doses (Part C)
기간: From dosing until day 6
|
Tmax is derived from the observed plasma concentration-time curves
|
From dosing until day 6
|
|
Terminal half-life [t(1/2)] following single oral ascending doses (Part A)
기간: From dosing until day 4
|
From dosing until day 4
|
|
|
Terminal half-life [t(1/2)] following single oral ascending doses (Part B)
기간: From dosing until day 8
|
From dosing until day 8
|
|
|
Terminal half-life [t(1/2)] following single oral ascending doses (Part C)
기간: From dosing until day 6
|
From dosing until day 6
|
|
|
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part A)
기간: From dosing until day 4
|
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
|
From dosing until day 4
|
|
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part B)
기간: From dosing until day 8
|
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
|
From dosing until day 8
|
|
Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part C)
기간: From dosing until day 6
|
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
|
From dosing until day 6
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Martine Géhin, PhD, Actelion
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 9월 12일
기본 완료 (실제)
2017년 12월 10일
연구 완료 (실제)
2017년 12월 10일
연구 등록 날짜
최초 제출
2016년 8월 31일
QC 기준을 충족하는 최초 제출
2016년 9월 14일
처음 게시됨 (추정)
2016년 9월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 7월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 7월 6일
마지막으로 확인됨
2018년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- AC-084-101
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
AC-084에 대한 임상 시험
-
AO GENERIUM모병
-
University of Maryland, BaltimoreNational Institute on Aging (NIA); Penn State University모병
-
CerecinCelerion완전한