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临床试验/NCT02084953
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

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

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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