Drug Interaction Study With Rosuvastatin

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Immunosuppression For Disease

Treatments: Drug: Rosuvastatin; Drug: BMS-986020

Study type: Interventional

Funder types: Industry

Identifiers

NCT02101125

IM136-122

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

26 participants in 1 patient group

BMS-986020 + Rosuvastatin (Treatment A, B and C)

Experimental group

Description:

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

Treatment:

Drug: BMS-986020

Drug: Rosuvastatin