Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Maximum observed plasma concentration (Cmax) of rosuvastatin
研究概览
简要总结
The purpose of this study is to assess the effect of the coadministration of multiple doses of BMS-663068 on the systemic exposure of rosuvastatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed Informed Consent Form
- •Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.
- •Target Population
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results.
- •Age and Reproductive Status
- •Men and women of non-childbearing potential, ages 18 to 50 years, inclusive. Women must have documented proof that they are not of childbearing potential. Women must not be breastfeeding.
- •Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).
排除标准
- •Women who are of childbearing potential or breastfeeding
- •Any significant acute or chronic medical illness
- •History of rhabdomyolysis or biliary disorders, including Gilbert's disease or Dubin-Johnson disease
- •Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration)
- •Alcohol intake exceeding 2 standard drinks per days; however, no alcohol is allowed 1 week prior to the start of study drug administration and for the duration of the study
- •Any other sound medical, psychiatric, and/or social reason as determined by the investigator
研究组 & 干预措施
Rosuvastatin and BMS-663068
Treatment A: Rosuvastatin, single dose (SD) Treatment B: BMS-663068 administered on specified days Treatment C: Combination BMS-663068 and Rosuvastatin administered on specified days
干预措施: Rosuvastatin (Drug)
Rosuvastatin and BMS-663068
Treatment A: Rosuvastatin, single dose (SD) Treatment B: BMS-663068 administered on specified days Treatment C: Combination BMS-663068 and Rosuvastatin administered on specified days
干预措施: BMS-663068 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of rosuvastatin
时间窗: Days 1 through 13
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) of rosuvastatin
时间窗: Days 1 through 13
次要结局
- Trough blood samples of BMS-626529 concentration(Days 7 through 13)
- Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.(40 days)