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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Aspirin; Drug: BMS-986177

Study type: Interventional

Funder types: Industry

Identifiers

NCT03341390

CV010-027

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 3 patient groups, including a placebo group

Aspirin

Active Comparator group

Description:

325 mg tablet, once daily for 5 days (Day -5 to -1)

Treatment:

Drug: Aspirin

BMS-986177 plus aspirin

Experimental group

Description:

200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7)

Treatment:

Drug: BMS-986177

Drug: Aspirin

Placebo plus aspirin

Placebo Comparator group

Description:

200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7)

Treatment:

Drug: Placebo

Drug: Aspirin