NCT02084953已完成1 期
A Randomized, Double-Blinded, Positive-Controlled, Placebo-Controlled, 3-Way Crossover Study to Determine the Electrocardiographic Effects of BMS-791325 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Difference from placebo of BMS-791325 in time-matched change from baseline (Day -1 on the study) to Day 3 of each period (ΔΔQTcF) at postdose extraction times for the QTcF
研究概览
简要总结
The purpose of this study is to determine whether BMS-791325 has an effect on the electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).
详细描述
Primary Purpose: Other: This Phase 1 study is a clinical pharmacology thorough QT study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy men and women, ages 18 to 49 yr old
- •BMI 18 to 32
- •Women must not be pregnant or breastfeeding
排除标准
- •Any significant acute or chronic medical illness
- •A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
- •History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
- •History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
- •Inability to swallow multiple tablets consecutively
- •Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration: PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec, Heart Rate (HR) < 45 bpm
- •Second or third degree heart block prior to study drug
- •Positive urine screen for drugs of abuse
- •Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody
- •Any of the following lab results outside of the ranges specified below prior to dosing: Alanine aminotransferase (ALT) > upper limit of normal (ULN), Aspartate aminotransferase (AST) > ULN, Total bilirubin > ULN, Direct bilirubin > ULN, Creatinine > ULN, Serum potassium < lower limit of normal (LLN), Serum magnesium < LLN
- •History of allergy to Moxifloxacin, BMS-791325, nonstructural protein 5B (NS5B) non-nucleoside inhibitors or related compounds
研究组 & 干预措施
ARM A: BMS-791325
Experimental
BMS-791325 600 mg tablet orally on 1st and 2nd day, then 900 mg on the 3rd day once a day for 3 days
干预措施: BMS-791325 (Drug)
ARM B: Moxifloxacin
Active Comparator
Moxifloxacin 400mg tablet orally once on third day
干预措施: Moxifloxacin (Drug)
ARM C: Placebo matching BMS-791325
Placebo Comparator
Placebo matching BMS-791325 0 mg tablet orally once daily for 3 days
干预措施: Placebo matching BMS-791325 (Drug)
结局指标
主要结局
Difference from placebo of BMS-791325 in time-matched change from baseline (Day -1 on the study) to Day 3 of each period (ΔΔQTcF) at postdose extraction times for the QTcF
时间窗: Approximately 28 days
次要结局
- ΔΔHR, ΔΔPR, ΔΔQRS, ΔΔQT(Approximately 28 days)
- Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-791325, BMS-794712, and BMS-948158(43 timepoints up to day 26)
- Number and percent of subjects having a within-period maximum HR, PR, QRS, QT, QTcF, ΔQT and ΔQTcF within prespecified categories(Approximately 28 days)
- Relationship between plasma concentrations of BMS-791325, BMS-794712, and BMS-948158, and the corresponding ΔΔQTcF(Approximately 28 days)
- Maximum observed concentration (Cmax) of BMS-791325, BMS-794712, and BMS-948158(43 timepoints up to day 26)
- AUC(TAU) metabolic ratios of BMS-791325, BMS-794712, and BMS-948158(43 timepoints up to day 26)
- Incidence of AEs, SAEs, AEs leading to discontinuation and death, marked laboratory abnormalities, findings on 12-lead safety ECG measurements and physical examination, and abnormalities in vital sign measurements exceeding pre-defined thresholds(Up to day 28)
- Difference from placebo of Moxifloxacin in change from baseline (Day -1) to Day 3 at postdose extraction times for the QTcF (ΔΔQTcF)(Approximately 28 days)
- Time of maximum observed concentration (Tmax) of BMS-791325, BMS-794712, and BMS-948158(43 timepoints up to day 26)
- Apparent total oral clearance (CLT/F) of BMS-791325, BMS-794712, and BMS-948158(43 timepoints up to day 26)
- Terminal phase plasma half life (T-HALF) of BMS-791325, BMS-794712, and BMS-948158(43 timepoints up to day 26)
研究者
研究点 (1)
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