NCT05162222已完成1 期
An Open-label, Randomized, 2-Period Crossover Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose Pharmacokinetics of Danicamtiv in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年12月15日最近更新:
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
- 30
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the effects of co-administration of itraconazole or diltiazem on the single-dose pharmacokinetics of danicamtiv in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18 and 30 kg/m^2, inclusive, at the Screening Visit
- •Normal ECG at the Screening Visit
- •Normal renal function at Screening
排除标准
- •History of ventricular arrhythmias
- •History of heart disease or conduction disorders
- •History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration)
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Danicamtiv, followed by itraconazole + danicamtiv
Experimental
干预措施: Danicamtiv (Drug)
Danicamtiv, followed by itraconazole + danicamtiv
Experimental
干预措施: Itraconazole (Drug)
Danicamtiv, followed by diltiazem + danicamtiv
Experimental
干预措施: Danicamtiv (Drug)
Danicamtiv, followed by diltiazem + danicamtiv
Experimental
干预措施: Diltiazem (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 17 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
时间窗: Up to 17 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
时间窗: Up to 17 days
次要结局
- Apparent terminal plasma half-life (T-HALF)(Up to 17 days)
- Incidence of adverse events (AEs)(Up to 28 days)
- Incidence of serious adverse events (SAEs)(Up to 28 days)
- Incidence of participants with vital sign abnormalities(Up to 17 days)
- Concentration at 24 hours (C24)(Up to 17 days)
- Time of maximum observed plasma concentration (Tmax)(Up to 17 days)
- Incidence of participants with electrocardiogram (ECG) abnormalities(Up to 17 days)
- Incidence of participants with physical exam abnormalities(Up to 17 days)
- Incidence of participants with clinical laboratory abnormalities(Up to 17 days)
研究者
研究点 (1)
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