Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Percent of Total Radioactivity Recovered in All Excreta (% total)
研究概览
简要总结
An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
- •Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.
排除标准
- •History of chronic illness
- •Chronic headaches
- •Recurrent dizziness
- •Personal or family history of heart disease
- •Personal history of bleeding diathesis
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986231 Intravenous Infusion
A single continuous intravenous infusion of BMS-986231
干预措施: BMS-986231 (Drug)
结局指标
主要结局
Percent of Total Radioactivity Recovered in All Excreta (% total)
时间窗: Up to 8 days
Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts
Total Body Clearance (CLT)
时间窗: Up to 8 days
Measured by plasma concentrations
Time to Maximum Observed Concentration (Tmax)
时间窗: Up to 8 days
Measured by plasma concentrations
Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
时间窗: Up to 8 days
Measured by plasma concentrations
Half-Life (T-HALF)
时间窗: Up to 8 days
Measured by plasma concentrations
Volume of Distribution during Terminal Elimination Phase (Vz/F)
时间窗: Up to 8 days
Measured by plasma concentrations
次要结局
- Incidence of adverse events (AEs)(Up to 8 days)
- Results of electrocardiogram tests (ECGs)(Up to 8 days)
- Results of vital sign measurements(Up to 8 days)
- Results of clinical laboratory tests(Up to 8 days)