A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Coadministration of Multiple Doses of BMS-986177 on Aspirin in Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of participants with vital sign abnormalities.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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 m
- •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.
Arms & Interventions
Aspirin
325 mg tablet, once daily for 5 days (Day -5 to -1)
Intervention: Aspirin (Drug)
BMS-986177 plus aspirin
200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Intervention: Aspirin (Drug)
BMS-986177 plus aspirin
200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Intervention: BMS-986177 (Drug)
Placebo plus aspirin
200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Intervention: Aspirin (Drug)
Placebo plus aspirin
200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of participants with vital sign abnormalities.
Time Frame: Up to 10 days
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)
Time Frame: 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)
Time Frame: Up to 10 days
Measured by electrocardiogram (ECG)
Number of participants with physical examination abnormalities.
Time Frame: Up to 10 days
Number of participants with clinical laboratory abnormalities.
Time Frame: Up to 10 days
Secondary Outcomes
No secondary outcomes reported