Immunosuppression For Disease
Conditions
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.
Interventions
DRUGBMS-986020
DRUGRosuvastatin
Sponsors
Bristol-Myers Squibb
Study design
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 to time of last quantifiable concentration (AUC(0-T)) 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 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Event (AEs), Serious Adverse Event (SAEs), deaths, and AEs leading to discontinuation | Upto Day 12 |
| Time of maximum observed plasma concentration (Tmax) 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 |
| 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 |
Countries
United States
Outcome results
None listed