Assessment of Regional Gastrointestinal Absorption of BMS-986165 Using Pharmacoscintigraphic Evaluation in Healthy Male Subjects
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
- Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D
研究概览
简要总结
The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
- •Estimated glomerular filtration rate (eGFR) > 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula
排除标准
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months of study drug administration) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug
- •Acute diarrhea, or constipation within 3 weeks prior to randomization
- •Any major surgery within 4 weeks of randomization
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Formulation E
Dosage formulation and area of release varies between arms
干预措施: BMS-986165 (Drug)
Formulation A
Dosage formulation and area of release varies between arms
干预措施: BMS-986165 (Drug)
Formulation B
Dosage formulation and area of release varies between arms
干预措施: BMS-986165 (Drug)
Formulation C
Dosage formulation and area of release varies between arms
干预措施: BMS-986165 (Drug)
Formulation D
Dosage formulation and area of release varies between arms
干预措施: BMS-986165 (Drug)
Formulation F
Dosage formulation and area of release varies between arms
干预措施: BMS-986165 (Drug)
Formulation G
Dosage formulation and area of release varies between arms
干预措施: BMS-986165 (Drug)
Formulation H
Dosage formulation and area of release varies between arms
干预措施: BMS-986165 (Drug)
结局指标
主要结局
Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D
时间窗: Determined over 5 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D
时间窗: Determined over 5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D
时间窗: Determined over 5 days
Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D
时间窗: Determined over 5 days
Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D
时间窗: Determined over 5 days
次要结局
- Pulse rate(Up to 60 days)
- Physical examination(Up to 60 days)
- Vital signs of body temperature(Up to 60 days)
- Vital sign of respiratory rate(Up to 60 days)
- Vital sign of supine blood pressure(Up to 60 days)
- Incidence of adverse events (AE)(Up to 90 days)
- Incidence of serious adverse events (SAE)(Up to 90 days)