An Investigational Study to Assess the Effect of BMS-986177 on Aspirin in Healthy Participants

• Status: Completed
• Trial end date: 2017-11-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of taking multiple doses of BMS-986177 when aspirin is taken once-daily. Eligible participants will receive twice-daily doses of BMS-986177 or placebo, with a once-daily dose of aspirin. The safety, tolerability and movement of BMS-986177 into, through and out of the body (pharmacokinetics/PK) will be assessed, as will the effect of BMS-986177 on the PK of aspirin.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Signed written consent form.

• Healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ECGs (electrocardiograms) and clinical laboratory determinations.

• Women participants must have documented proof they are not of childbearing potential.

• Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with BMS-986177, and for a total of 93 days after the last dose of BMS-986177; and must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements.

• Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2.

• Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.

Exclusion Criteria:

• Women who are of childbearing potential or breastfeeding.

• Any significant acute or chronic illness.

• History of gastroesophageal reflux disease, dyspepsia, protracted nausea or chronic diarrhea.

• History of upper gastrointestinal ulcer disease within 6 months or current symptomatic or recent gastrointestinal disease that could impact absorption of study treatment.

• Abnormal renal profile and/or hematuria (if male) within 3 months of study start.

• History or evidence of abnormal bleeding and/or coagulation disorder and/or evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, or a history of spontaneous bleeding.

• Any major surgery within 4 weeks of study treatment administration or planned within 2 weeks after completion of the study.

• Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study treatment administration (within 2 weeks for plasma only).

• Blood transfusion within 3 months of study treatment administration.

• Use of tobacco- or nicotine-containing products (including, but not limited to cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges or nicotine gum) within 6 months prior to study treatment administration.

• History of allergy to aspirin or related compounds.

Other protocol-defined inclusion/exclusion criteria could apply.