A Phase 1 interventional study of Aspirin and BMS-986177 in Healthy Volunteers, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-19.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Basic science
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.
Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply.
325 mg tablet, once daily for 5 days (Day -5 to -1)
Drug: Aspirin
200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Drug: Aspirin · Drug: BMS-986177
200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Drug: Aspirin · Drug: Placebo
1 x 325 mg tablet of aspirin administered once daily
Also known as: Acetylsalicylic Acid
200 mg of BMS-986177 administered twice daily
200 mg of Placebo administered twice daily
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)
Safety and tolerability of multiple doses of BMS-986177 measured by investigator assessment
Time frame: Up to 10 days
Number of potential clinically significant changes in electrical activity of the heart in participants coadministered BMS-986177 (twice daily) and aspirin (once daily)
Measured by electrocardiogram (ECG)
Time frame: Up to 10 days
Number of participants with vital sign abnormalities.
Time frame: Up to 10 days
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
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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