Healthy Volunteers
Conditions
Keywords
Healthy participants, Healthy subjects, Strokes
Brief 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.
Interventions
DRUGAspirin
1 x 325 mg tablet of aspirin administered once daily
DRUGBMS-986177
200 mg of BMS-986177 administered twice daily
DRUGPlacebo
200 mg of Placebo administered twice daily
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation when coadministered BMS-986177 (twice daily) and aspirin (once daily) | Up to 10 days | Safety and tolerability of multiple doses of BMS-986177 measured by investigator assessment |
| Number of potential clinically significant changes in electrical activity of the heart in participants coadministered BMS-986177 (twice daily) and aspirin (once daily) | Up to 10 days | Measured by electrocardiogram (ECG) |
| Number of participants with vital sign abnormalities. | Up to 10 days | — |
| Number of participants with physical examination abnormalities. | Up to 10 days | — |
| Number of participants with clinical laboratory abnormalities. | Up to 10 days | — |
Countries
United States
Outcome results
None listed