NCT05686096已完成1 期
A Phase 1, Open-label, Single Dose Study to Assess the Absorption, Metabolism, and Excretion of [14C]BMS-986435 in Healthy Male Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2023年1月16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
- 7
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
研究概览
简要总结
The purpose of this study is to determine the absorption, metabolism, excretion; and to evaluate the safety and tolerability of BMS-986435 in healthy male participants
Participants will be admitted to the study site for 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18 and 32 kg/m^2, inclusive, at screening. - Healthy male participants as determined by the investigator and sponsor.
- •Adequate acoustic windows to enable accurate transthoracic echocardiogram (TTE) assessment of parameters of left ventricular (LV) systolic function by TTE.
- •Documented left ventricular ejection fraction (LVEF) ≥ 60% at screening.
排除标准
- •Any acute or chronic medical illness.
- •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).
- •Head injury in the last 2 years, intracranial tumor, or aneurysm. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
MYK-224
Experimental
干预措施: MYK-224 (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
时间窗: Up to 45 days
Maximum observed concentration (Cmax)
时间窗: Up to 45 days
Time to maximum observed concentration (Tmax)
时间窗: Up to 45 days
次要结局
- Metabolite profiling of BMS-986435 in plasma, urine, and feces(Up to 45 days)
- Number of participants with adverse events (AEs)(Up to 45 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 45 days)
- Number of participants with clinical laboratory abnormalities(Up to 45 days)
- Number of participants with vital sign abnormalities(Up to 45 days)
- Number of participants with physical examination abnormalities(Up to 45 days)
研究者
研究点 (1)
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