NCT03004768已完成1 期
Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2017年1月26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
- 6
- 试验地点
- 1
- 主要终点
- The primary endpoint is PK exposure that will be determined from plasma concentration versus time
研究概览
简要总结
An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165
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 of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m
- •No evidence of acute infection or other significant problem as determined from a review of a chest x-ray, medical history, and physical examination
排除标准
- •History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
- •Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
- •Participant with greater than Grade 2 acne.
- •Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.
研究组 & 干预措施
Single dose of radiolabeled BMS-986165
Experimental
干预措施: BMS-986165 (Drug)
结局指标
主要结局
The primary endpoint is PK exposure that will be determined from plasma concentration versus time
时间窗: Day 1 to Day 13
Urinary/fecal TRA (Total radioactivity) recovery data
时间窗: Day 1 to Day 13
PK time of maximum observed plasma concentration (Tmax)
时间窗: Day 1 to Day 13
PK terminal elimination half-life data (T-HALF)
时间窗: Day 1 to Day 13
PK apparent total body clearance (CL/F)
时间窗: Day 1 to Day 13
PK apparent volume of distribution (Vz/F)
时间窗: Day 1 to Day 13
次要结局
- Safety endpoints include the incidence of adverse events (AEs)(Day 1 to Day 13)
- Safety endpoints include the results of electrocardiogram tests (ECGs)(Day 1 to Day 13)
- Safety endpoints include the results of vital signs(Day 1 to Day 13)
- Safety endpoints include the results of physical exams(Day 1 to Day 13)
- Safety endpoints include the results of clinical laboratory tests(Day 1 to Day 13)
研究者
研究点 (1)
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