Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529 From an Extended-Release Formulation of BMS-663068 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food
研究概览
简要总结
The current food effect study is being performed to support a Phase 3 study with BMS 663068. Results from this study will inform whether patients in the upcoming Phase 3 study can be given the flexibility to dose BMS-663068 in the fasted state, if so desired.
详细描述
Primary Purpose: Other: To assess the effect of food on the steady-state exposure of BMS-626529 when administered as BMS 663068 600 mg twice daily (BID) to healthy subjects
Acquired Immune Deficiency Syndrome (AIDS)
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 and surgical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory test results
- •Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- •Males and Females, ages 18 to 50 years, inclusive
- •Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within 24 hours prior to the start of study drug
排除标准
- •Any significant acute or chronic medical illness as determined by the investigator
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
- •Any major surgery within 4 weeks of study drug administration
- •Any gastrointestinal surgery that could impact upon the absorption of study drug
- •Inability to tolerate oral medication
- •Recent (within 6 months of study drug administration) history of smoking or current smokers
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations beyond what is consistent with the target population
- •Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat:
- •PR ≥ 210 msec
- •QRS ≥ 120 msec
- •QT ≥ 500 msec
- •QTcF ≥ 450 msec
- •Positive urine screen for drugs of abuse
- •Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus-1 (HIV-1), -2 antibodies, and HIV-1 RNA
研究组 & 干预措施
BMS-663068- Fasted
BMS-663068 tablet twice a day by mouth on specified days
干预措施: BMS-663068 (Drug)
BMS-663068- Fed
BMS-663068 tablet twice a day by mouth on specified days
干预措施: BMS-663068 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food
时间窗: Days 1-4 of Periods 1 and 2
Area under the concentration-time curve in one dosing interval (AUC(TAU)) for BMS-626529 in the presence and absence of food
时间窗: Days 1-4 of Periods 1 and 2
次要结局
- Trough observed plasma concentration (Ctrough) of BMS-626529(Days 1-4 of each period)
- Safety and tolerability endpoints including incidence of Adverse events (AEs), serious AEs, AEs leading to discontinuations, deaths, and the results of vital signs, ECGs, physical examinations, and clinical laboratory tests(Approximately up to 41 days)
- Plasma concentration observed at 12 hours postdose (C12) of BMS-626529(Day 4 of each period)
- Time of maximum observed plasma concentration (Tmax) of BMS-626529(Day 4 of each period)