Status:
COMPLETED
An Investigational Study to Assess the Effect of BMS-986177 on Aspirin in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03341390
Start Date
October 18 2017
End Date
November 16 2017
Last Update
January 19 2018
Active Locations (1)
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1
PPD Austin Clinic
Austin, Texas, United States, 78744