A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Concomitant Administration of BMS-986020 on the Single-dose Pharmacokinetics of Rosuvastatin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) of Rosuvastatin with and without coadministered BMS-986020
研究概览
简要总结
The purpose of this study is to evaluate the effect of concomitant administration of BMS-986020 on the single dose Pharmacokinetics (PK) of Rosuvastatin in healthy subjects.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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 who have no clinically significant deviation from normal in medical history, surgical history, PE, vital signs, ECG, and clinical laboratory determinations
- •Nonsmokers
- •Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive. Men, ages 18 to 50 years, inclusive
- •Men and women, 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 HCG) within 24 hours prior to the start of investigational product
- •Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) (11 days) plus 5 half-lives of the study drug (4 days) plus 90 days (duration of sperm turnover) for a total of 94 days posttreatment completion
排除标准
- •Any significant acute or chronic medical illness
- •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 (eg, partial gastrectomy, pyloroplasty) including cholecystectomy that could impact upon the absorption of study drug
- •Donation of > 400 mL of blood within 8 weeks or donation of plasma (except at screening visit) within 4 weeks of study drug administration
- •Blood transfusion within 4 weeks of study drug administration
- •Inability to tolerate oral medication
- •Inability to be venipunctured and/or tolerate venous access as determined by the investigator
- •Use of tobacco-containing or nicotine containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to check-in, or a positive nicotine test (ie, cotinine) at screening or check-in
- •Subjects who drink more than 3 cups of coffee or other caffeine containing products with an equivalent amount of caffeine per day, or 5 cups of tea per day
- •History of allergy to Lysophosphatidic acid (LPA1) antagonists or related compounds
研究组 & 干预措施
BMS-986020 + Rosuvastatin (Treatment A, B and C)
Cohort 1: Rosuvastatin Tablet Single dose and BMS- 986020 orally on specific days
Cohort 2 (Administered 4 hrs, after the morning dose of BMS-986020): Rosuvastatin Tablet Single dose and BMS- 986020 orally on specific days
干预措施: BMS-986020 (Drug)
BMS-986020 + Rosuvastatin (Treatment A, B and C)
Cohort 1: Rosuvastatin Tablet Single dose and BMS- 986020 orally on specific days
Cohort 2 (Administered 4 hrs, after the morning dose of BMS-986020): Rosuvastatin Tablet Single dose and BMS- 986020 orally on specific days
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of Rosuvastatin with and without coadministered BMS-986020
时间窗: 31 timepoints up to Day 12
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin with and without coadministered BMS-986020
时间窗: 31 timepoints up to Day 12
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin with and without coadministered BMS-986020
时间窗: 31 timepoints up to Day 12
次要结局
- Terminal plasma half-life (T-HALF) of Rosuvastatin with and without coadministered BMS-986020(31 timepoints up to Day 12)
- Apparent total body clearance (CLT/F) of Rosuvastatin with and without coadministered BMS-986020(31 timepoints up to Day 12)
- Results of vital signs, ECGs, Physical Examination (PEs), and clinical lab result(Up to Day 12)
- Time of maximum observed plasma concentration (Tmax) of Rosuvastatin with and without coadministered BMS-986020(31 timepoints up to Day 12)
- Incidence of Adverse Event (AEs), Serious Adverse Event (SAEs), deaths, and AEs leading to discontinuation(Upto Day 12)