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
2018年7月6日 更新者：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
研究概览
详细说明
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
研究类型
介入性
注册 (实际的)
56
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Leeds、英国、LS2 9LH
- Covance Clinical Research Unit
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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)
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Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
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安慰剂比较：Placebo,single ascending dose (Part A)
Matched placebo administered as single ascending doses in parallel to AC-084
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Placebo capsules matching AC-084 capsules
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实验性的：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)
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Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
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安慰剂比较：Placebo,multiple ascending dose (Part B)
Matched placebo administered as multiple ascending doses in parallel to AC-084
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Placebo capsules matching AC-084 capsules
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实验性的：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)
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Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of participants with adverse events (AEs) (Part A)
大体时间：From dosing until day 4
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Treatment-emergent AEs and treatment-emergent serious AEs
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From dosing until day 4
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Number of participants with adverse events (AEs) (Part B)
大体时间：From dosing until day 8
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Treatment-emergent AEs and treatment-emergent serious AEs
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From dosing until day 8
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Number of participants with adverse events (AEs) (Part C)
大体时间：From dosing until day 6
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Treatment-emergent AEs and treatment-emergent serious AEs
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From dosing until day 6
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Incidence of safety events of interest (Part A)
大体时间：From dosing until day 4
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Events of interest are any abnormalities in ECG, vital signs or laboratory test results
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From dosing until day 4
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Incidence of safety events of interest (Part B)
大体时间：From dosing until day 8
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Events of interest are any abnormalities in ECG, vital signs or laboratory test results
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From dosing until day 8
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Incidence of safety events of interest (Part C)
大体时间：From dosing until day 6
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Events of interest are any abnormalities in ECG, vital signs or laboratory test results
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From dosing until day 6
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Maximum plasma concentration (Cmax) following single oral ascending doses (Part A)
大体时间：From dosing until day 4
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Cmax is derived from the observed plasma concentration-time curves
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From dosing until day 4
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Maximum plasma concentration (Cmax) following single oral ascending doses (Part B)
大体时间：From dosing until day 8
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Cmax is derived from the observed plasma concentration-time curves
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From dosing until day 8
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Maximum plasma concentration (Cmax) following single oral ascending doses (Part C)
大体时间：From dosing until day 6
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Cmax is derived from the observed plasma concentration-time curves
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From dosing until day 6
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Time to reach Cmax (tmax) following single oral ascending doses (Part A)
大体时间：From dosing until day 4
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Tmax is derived from the observed plasma concentration-time curves
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From dosing until day 4
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Time to reach Cmax (tmax) following single oral ascending doses (Part B)
大体时间：From dosing until day 8
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Tmax is derived from the observed plasma concentration-time curves
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From dosing until day 8
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Time to reach Cmax (tmax) following single oral ascending doses (Part C)
大体时间：From dosing until day 6
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Tmax is derived from the observed plasma concentration-time curves
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From dosing until day 6
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Terminal half-life [t(1/2)] following single oral ascending doses (Part A)
大体时间：From dosing until day 4
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From dosing until day 4
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Terminal half-life [t(1/2)] following single oral ascending doses (Part B)
大体时间：From dosing until day 8
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From dosing until day 8
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Terminal half-life [t(1/2)] following single oral ascending doses (Part C)
大体时间：From dosing until day 6
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From dosing until day 6
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Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part A)
大体时间：From dosing until day 4
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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
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From dosing until day 4
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Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part B)
大体时间：From dosing until day 8
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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
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From dosing until day 8
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Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part C)
大体时间：From dosing until day 6
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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
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From dosing until day 6
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Martine Géhin, PhD、Actelion
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年9月12日
初级完成 (实际的)
2017年12月10日
研究完成 (实际的)
2017年12月10日
研究注册日期
首次提交
2016年8月31日
首先提交符合 QC 标准的
2016年9月14日
首次发布 (估计)
2016年9月19日
研究记录更新
最后更新发布 (实际的)
2018年7月10日
上次提交的符合 QC 标准的更新
2018年7月6日
最后验证
2018年7月1日
更多信息
与本研究相关的术语
其他研究编号
- AC-084-101
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
AC-084的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA); Penn State University主动，不招人