Drug Interaction Study With Rosuvastatin
Phase 1
Completed
- Conditions
- Immunosuppression For Disease
- Interventions
- Registration Number
- NCT02101125
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986020 + Rosuvastatin (Treatment A, B and C) BMS-986020 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 BMS-986020 + Rosuvastatin (Treatment A, B and C) Rosuvastatin 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
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) of Rosuvastatin with and without coadministered BMS-986020 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 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 31 timepoints up to Day 12
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Healthcare Discoveries, Llc D/B/A Icon Development Solutions
🇺🇸San Antonio, Texas, United States