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

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
BMS-986177 plus aspirin	BMS-986177	200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Placebo plus aspirin	Placebo	200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Aspirin	Aspirin	325 mg tablet, once daily for 5 days (Day -5 to -1)
BMS-986177 plus aspirin	Aspirin	200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Placebo plus aspirin	Aspirin	200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7)

Primary Outcome Measures

Name	Time	Method
Number of participants with vital sign abnormalities.	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)	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 physical examination abnormalities.	Up to 10 days
Number of participants with clinical laboratory abnormalities.	Up to 10 days

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility