Drug Interaction Study With Rosuvastatin

Completed · Phase 1

Conditions studied: Immunosuppression For Disease

In brief

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.

Key facts

Study ID

NCT02101125

Run by

Bristol-Myers Squibb

People needed

26

Starts

2014-03-01

Expected to finish

2014-05-01

Last updated by the study team

2014-06-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Healthcare Discoveries, Llc D/B/A Icon Development Solutions — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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