NCT06476821已完成1 期
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月27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
- 20
- 试验地点
- 1
- 主要终点
- Time of maximum observed concentration (Tmax)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics following a single oral dose of BMS-986435 in healthy adult Chinese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight of ≥ 50 kg and body mass index between 18.0 and 28.0 kg/m2, inclusive, at screening.
- •Participants must be Chinese (both biological parents are ethnically Chinese).
- •Participant has documented LVEF ≥ 60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.
排除标准
- •Any acute or chronic medical illness.
- •Head injury in the last 2 years, intracranial tumor, or aneurysm.
- •History of malignancy of any type, except in situ cervical cancer > 5 years prior to the screening visit or surgically excised nonmelanomatous skin cancers > 2 years prior to the screening visit.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm 1
Experimental
干预措施: BMS-986435 (Drug)
Arm 2
Experimental
干预措施: BMS-986435 (Drug)
结局指标
主要结局
Time of maximum observed concentration (Tmax)
时间窗: Up to Day 30
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 Day 30
Maximum observed concentration (Cmax)
时间窗: Up to Day 30
次要结局
- Number of participants with AEs leading to discontinuation(From date of written consent up to 28 days post last dose)
- Number of participants with Adverse Events(From date of written consent up to 28 days post last dose)
- Number of participants with Serious Adverse Events(From date of written consent up to 28 days post last dose)
- Number of participants with vital sign abnormalities(Up to Day 31)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 31)
- Number of participants with physical examination abnormalities(Up to Day 31)
- Echocardiographic measures of cardiac systolic function: left ventricular ejection fraction (LVEF)(Up to Day 30)
- Echocardiographic measures of cardiac systolic function: left ventricular fractional shortening (LVFS)(Up to Day 30)
- Echocardiographic measures of cardiac systolic function: left ventricle stroke volume (LVSV)(Up to Day 30)
- Echocardiographic measures of cardiac diastolic function: lateral early diastolic mitral annular velocity (e')(Up to Day 30)
- Echocardiographic measures of cardiac structure: posterior wall thickness(Up to Day 30)
- Echocardiographic measures of cardiac systolic function: left ventricular outflow tract velocity time integral (LVOT-VTI)(Up to Day 30)
- Echocardiographic measures of cardiac diastolic function: septal e'(Up to Day 30)
- Echocardiographic measures of cardiac diastolic function: early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e')(Up to Day 30)
- Echocardiographic measures of cardiac diastolic function: early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio)(Up to Day 30)
- Echocardiographic measures of cardiac structure: LV mass index(Up to Day 30)
- Echocardiographic measures of cardiac structure: LV atrial volume index(Up to Day 30)
- Echocardiographic measures of cardiac structure: interventricular septal thickness(Up to Day 30)
- Echocardiographic measures of cardiac structure: LV end systolic volume(Up to Day 30)
- Number of participants with echocardiogram abnormalities(Up to Day 30)
- Number of participants with clinical laboratory abnormalities(Up to Day 31)
- Echocardiographic measures of cardiac systolic function: left ventricular global longitudinal strain (LV GLS)(Up to Day 30)
- Echocardiographic measures of cardiac structure: LV end diastolic volume(Up to Day 30)
- Echocardiographic measures of cardiac structure: LV end systolic volume index(Up to Day 30)
研究者
研究点 (1)
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