A Randomized, Double-Blind, Double-Dummy, Positive-Controlled, Crossover Study to Determine Electrocardiographic Effects of BMS-955176 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Part 1: Safety 12-lead ECGs
研究概览
简要总结
The purpose of the study is to determine the effect of multiple doses of BMS-955176 on the QT interval corrected with Fridericia's method (QTcF) in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written Informed Consent
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
- •Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day
- •BMI = weight (kg)/[height(m)]2
- •Women must have a negative serum pregnancy test, must not be breastfeeding, and women of child bearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period
- •Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period
排除标准
- •Any significant acute or chronic medical illness
- •Any GI disease or surgery that can affect absorption of the study drug
- •A personal history of clinically relevant cardiac disease, long QT syndrome, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- •History of allergy to moxifloxacin, HIV maturation inhibitors, or related compounds
研究组 & 干预措施
Part 1: Sentinal Cohorts
Study is in 2 sequential cohorts (BMS-955176 or placebo) each to evaluate the safety, tolerability, and PK following multiple-dose administration of BMS-955176.
干预措施: BMS-955176, Placebo (Part 1) (Drug)
Part 2: Main QTc Study
3 period nested crossover study.
干预措施: BMS-955176, Moxifloxacin, Placebo (Part 2) (Drug)
结局指标
主要结局
Part 1: Safety 12-lead ECGs
时间窗: Selected time points up to 24 hours postdose
Part 1: Physical examinations
时间窗: Selected time points up to 24 hours postdose
Part 2: ΔΔQTcF, the subject specific time-matched difference between the ΔQTcF (QT interval corrected with Fridericia's method) after administration of BMS-955176 and the ΔQTcF after administration of placebo
时间窗: Days 1 to 28
Part 1: Vital sign measurements
时间窗: Selected time points up to 24 hours postdose
Part 1: Reported adverse events
时间窗: Selected time points up to 24 hours postdose
次要结局
未报告次要终点