Pharmacokinetics and Metabolism of [14C] BMS-986205 in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
研究概览
简要总结
Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Body weight 75-95kg, BMI 18.0-32.0 kg/m^2
- •Refrain from sperm donation 110 days after dosing
排除标准
- •Current or recent gastrointestinal disease
- •Any GI surgery that could impact drug absorption
- •Active, known, or suspected autoimmune disease
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Single Oral Dose of BMS-986205
干预措施: BMS-986205 (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
时间窗: up to 28 days
Measured by plasma concentrations
Half-Life (T-HALF)
时间窗: up to 28 days
Measured by plasma concentrations
Total Body Clearance (CLT)
时间窗: up to 28 days
Measured by plasma concentrations
Percent of Total Radioactivity Recovered in All Excreta (% total)
时间窗: up to 28 days
Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts
Volume of Distribution during Terminal Elimination Phase (Vz/F)
时间窗: up to 28 days
Measured by plasma concentrations
Time to Maximum Observed Concentration (Tmax)
时间窗: up to 28 days
Measured by plasma concentrations
次要结局
- Results of electrocardiogram tests (ECGs)(up to 28 days)
- Results of clinical laboratory tests(up to 28 days)
- Incidence of adverse events (AEs)(up to 28 days)
- Results of vital sign measurements(up to 28 days)