NCT01211808已完成1 期
Effect of Diltiazem on the Pharmacokinetics of BMS-914392 and on Heart Rate After Single-dose Administration of BMS-914392 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年9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
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of single dose of BMS-914393 derived from serial measurements of BMS-914392 plasma concentrations
研究概览
简要总结
The purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of single-dose BMS-914392 in healthy subjects.
详细描述
Protocol designed to evaluate the potential for a drug-drug interaction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy
排除标准
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease
- •Current or history of neurological diseases or psychiatric disorders and cardiovascular diseases
研究组 & 干预措施
Treatment A (BMS-914832)
Experimental
干预措施: BMS-914832 (Drug)
Treatment B (BMS-914832 + diltiazem)
Experimental
干预措施: BMS-914832 (Drug)
Treatment B (BMS-914832 + diltiazem)
Experimental
干预措施: Diltiazem (Drug)
结局指标
主要结局
Pharmacokinetics of single dose of BMS-914393 derived from serial measurements of BMS-914392 plasma concentrations
时间窗: Pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, and 96 hours after dosing of BMS-914392 alone or in combination with diltiazem
次要结局
- The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial electrocardiograms (ECGs)(Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr , 6 Hr, 8 Hr, 12 Hr, 24 Hr after dosing of BMS-914392 alone or in combination with diltiazem)
- Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392(Daily)
研究者
研究点 (1)
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