Assessment of BMS-955176 Bioavailability From a Micronized Crystalline Tablet Relative to a Spray-Dried Dispersion Suspension and Assessment of Additional Experimental Formulations Relative to the Micronized Crystalline Tablet in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) of BMS-955176
研究概览
简要总结
The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.
详细描述
Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG) measurements and clinical laboratory test results
- •Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg) / [height (m)]2
- •Men and women, ages 18 to 50 years, inclusive
- •Women must not be of childbearing potential, must not be breastfeeding
排除标准
- •Any significant acute or chronic medical illness
- •History of cardiac disease or clinically significant cardiac arrhythmias
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease
- •Any major surgery within 4 weeks of study drug administration
- •Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
研究组 & 干预措施
Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C)
BMS-955176 single dose by mouth as specified
干预措施: BMS-955176 (Drug)
Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A)
BMS-955176 single dose by mouth as specified
干预措施: BMS-955176 (Drug)
Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C)
BMS-955176 single dose by mouth as specified
干预措施: BMS-955176 (Drug)
Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B)
BMS-955176 single dose by mouth as specified
干预措施: BMS-955176 (Drug)
Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H)
BMS-955176 single dose by mouth as specified
干预措施: BMS-955176 (Drug)
Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E)
BMS-955176 single dose by mouth as specified
干预措施: BMS-955176 (Drug)
Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G)
BMS-955176 single dose by mouth as specified
干预措施: BMS-955176 (Drug)
Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F)
BMS-955176 single dose by mouth as specified
干预措施: BMS-955176 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of BMS-955176
时间窗: Days 1-4 of Periods 1, 2, 3 and 4
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176
时间窗: Days 1-4 of Periods 1, 2, 3 and 4
Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176
时间窗: Days 1-4 of Periods 1, 2, 3 and 4
次要结局
- Time of maximum observed plasma concentration (Tmax) of BMS-955176(Days 1-4 of Periods 1, 2, 3 and 4)
- Terminal plasma half-life (T-HALF) of BMS-955176(Days 1-4 of Periods 1, 2, 3 and 4)
- Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations(Up to Period 4/Day 4 (discharge))
- Apparent total body clearance (CLT/F) of BMS-955176(Days 1-4 of Periods 1, 2, 3 and 4)