An Investigational Study to Assess the Effect of BMS-986177 on Aspirin in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/21/2018 |
| Start Date: | October 18, 2017 |
| End Date: | November 16, 2017 |
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
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.
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.
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.
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