A Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define Lanifibranor (IVA337) Supra-therapeutic Dose in a Multiple Dosing Regimen
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of Adverse events
研究概览
简要总结
The study will be a double-blind, randomized, placebo-controlled, multiple ascending dose study with lanifibranor. The study will consist of up to 3 cohorts of 12 subjects each; therefore, approximately 36 subjects will be included in this study.
详细描述
All subject will receive first a single dose of 400 mg moxifloxacin, under open-label fasting conditions at Day -8 (assay sensitivity).
Following, all subjects also will receive a dose of placebo under open-label fasting conditions at D-1.
In the morning of Day 1, subjects will be randomized to either the investigational medicinal product (IMP) or placebo (3:1). The treatment phase last 14 days and the end of study visit will occurs within 5 to 9 days after the last dose of IMP or placebo (or at early termination)
A staggered dose approach will be applied within each subjects cohort with 48 hours of delay between subcohorts.
A sefty review committe (SRC) will review after each cohorts all available safety and PK data under blinded conditions and conclude the safety and tolerability of the dose level before proceeding to the next dose level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo to Match
干预措施: Placebo (Drug)
Experimental
IMP Under investigation
干预措施: Moxifloxacin (Drug)
Experimental
IMP Under investigation
干预措施: Placebo (Drug)
Experimental
IMP Under investigation
干预措施: Lanifibranor (Drug)
Placebo to Match
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Number of Adverse events
时间窗: From Baseline up to 15 days
Number of abnormal Clinical laboratory tests (chemistry, hematology, urinalysis)
时间窗: From Baseline up to 15 days
Number of abnormal Vital signs (blood pressure, pulse) and physical exams
时间窗: From Baseline up to 15 days
Number of abnormal 12-lead digital electrocardiograms parameters (Heart rate, QT/QTc interval, PR interval, QRS interval, RR interval) change from baseline
时间窗: From Baseline up to 15 days
次要结局
- Maximum plasma concentration (Cmax) of lanifibranor and its metabolites(15 days)
- Time of maximum plasma concentration (Tmax) of lanifibranor and its metabolites(15 days)
- Number of Cardiovascular safety events(From Baseline up to 15 days)
- Area under the concentration-time curve (AUC0-t) of lanifibranor and its metabolites(From Baseline up to 15 days)