A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of BMS-919373 on the Single-dose Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 主要终点
- Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin
研究概览
简要总结
This purpose of this study is to assess the effects of BMS-919373 on the single dose Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.
详细描述
Primary Purpose: Other - To assess the effects of BMS-919373 on the single dose PK of Rosuvastatin and Atorvastatin in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Written Informed Consent form
- •Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, physical measurements, vital signs, 12-lead ECG, 24-hour telemetry, and clinical laboratory tests
- •Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- •Men and women, ages 18 to 55 yrs, inclusive
排除标准
- •Current or history of cardiovascular diseases, including arrhythmias, coronary heart disease, and congestive heart failure
- •Current or history of symptomatic hypotension
- •Current or history of liver diseases, including cirrhosis and liver failure
- •Current or history of kidney diseases, including nephrotic syndrome, renal failure, nephrolithiasis, and urolithiasis
- •Current or history of neurological diseases, including presyncope, syncope, convulsive disorders such as epilepsy, cerebral thrombosis and cerebral embolism, transient ischemic attack, and stroke; or mental disorders Exceptions for presyncope/syncope related to vasovagal responses are allowable at the discretion of the investigator
- •History of significant head injury in the last 2 years
研究组 & 干预措施
Cohort 1: Rosuvastatin + BMS-919373
Rosuvastatin 10 mg tablet orally once for Day 1 and 5
BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension
干预措施: BMS-919373 (Drug)
Cohort 1: Rosuvastatin + BMS-919373
Rosuvastatin 10 mg tablet orally once for Day 1 and 5
BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension
干预措施: Rosuvastatin (Drug)
Cohort 2: Atorvastatin + BMS-919373
Atorvastatin 40 mg tablet once for Days 1 and 5
BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension
干预措施: BMS-919373 (Drug)
Cohort 2: Atorvastatin + BMS-919373
Atorvastatin 40 mg tablet once for Days 1 and 5
BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin
时间窗: 28 timepoints up to day 10
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin
时间窗: 28 timepoints up to day 10
Area under the plasma concentration-time curve from time zero to 72 hours (AUC(0-72)) of Rosuvastatin and Atorvastatin
时间窗: 26 timepoints up to day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin and Atorvastatin
时间窗: 28 timepoints up to day 10
次要结局
- Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin(28 timepoints up to day 10)
- Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin(28 timepoints up to day 10)
- Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin(28 timepoints up to day 10)
- Safety based on results of physical examinations, vital sign measurements, ECGs, 24-hour telemetry, clinical laboratory tests, and physical measurements and will also include the incidence of AEs, SAEs and AEs leading to discontinuation(Up to day 10)