An Investigational Study to Assess the Effect of BMS-986177 on Aspirin in Healthy Participants
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Aspirin 325 mg tablet, once daily for 5 days (Day -5 to -1) |
Drug: Aspirin
1 x 325 mg tablet of aspirin administered once daily
Other Names:
|
Experimental: BMS-986177 plus aspirin 200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7) |
Drug: Aspirin
1 x 325 mg tablet of aspirin administered once daily
Other Names:
Drug: BMS-986177
200 mg of BMS-986177 administered twice daily
|
Placebo Comparator: Placebo plus aspirin 200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7) |
Drug: Aspirin
1 x 325 mg tablet of aspirin administered once daily
Other Names:
Drug: Placebo
200 mg of Placebo administered twice daily
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed written consent form.
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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.
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Women participants must have documented proof they are not of childbearing potential.
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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.
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Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2.
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Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.
Exclusion Criteria:
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Women who are of childbearing potential or breastfeeding.
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Any significant acute or chronic illness.
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History of gastroesophageal reflux disease, dyspepsia, protracted nausea or chronic diarrhea.
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History of upper gastrointestinal ulcer disease within 6 months or current symptomatic or recent gastrointestinal disease that could impact absorption of study treatment.
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Abnormal renal profile and/or hematuria (if male) within 3 months of study start.
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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.
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Any major surgery within 4 weeks of study treatment administration or planned within 2 weeks after completion of the study.
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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).
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Blood transfusion within 3 months of study treatment administration.
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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.
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History of allergy to aspirin or related compounds.
Other protocol-defined inclusion/exclusion criteria could apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | PPD Austin Clinic | Austin | Texas | United States | 78744 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CV010-027