Drug Interaction Study With Rosuvastatin

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Rosuvastatin Calcium

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