NCT07723118招募中1 期
A Phase 1, Single-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Adagrasib (BMS-986503) in Healthy Participants of Japanese Descent
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Apparent Total Body Clearance (CLT/F)
研究概览
简要总结
The aim of this study is to assess the pharmacokinetics, safety and tolerability of single-dose Adagrasib (BMS-986503) in healthy participants of Japanese descent
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be of Japanese descent (both biological parents of the participant are ethnically Japanese).
- •Participants must be healthy adult without clinically significant deviation from normal in medical history, PE, 12-lead ECG, vital sign measurements, and clinical laboratory assessments as determined by the investigator.
- •Participants must have Body mass index of 18.0 kg/m2 to 32.0 kg/m
- •Participants must have Total body weight ≥ 50 kg.
排除标准
- •Participants must not have significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.
- •Other protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Adagrasib
Experimental
干预措施: Adagrasib (Drug)
结局指标
主要结局
Apparent Total Body Clearance (CLT/F)
时间窗: Up to Day 7
Volume of Distribution of Terminal Phase (Vz/F)
时间窗: Up to Day 7
Maximum Observed Plasma Concentration (Cmax)
时间窗: Up to Day 7
Time of Maximum Observed Plasma Concentration
时间窗: Up to Day 7
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
时间窗: Up to Day 7
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
时间窗: Up to Day 7
Apparent Terminal Phase Half-life (T-HALF)
时间窗: Up to Day 7
次要结局
- Number of Participants with Treatment Emergent Adverse Events (AEs)(Up to Day 13)
- Number of Participants with Clinical Laboratory Test Abnormalities(Up to Day 7)
- Number of Participants with Vital Sign Abnormalities(Up to Day 7)
- Number of Participants with Physical Examination (PE) Abnormalities(Up to Day 7)
- Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities(Up to Day 7)
研究者
研究点 (1)
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