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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 16, 2017

Interventions

  • Drug: Aspirin
    • 1 x 325 mg tablet of aspirin administered once daily
  • Drug: BMS-986177
    • 200 mg of BMS-986177 administered twice daily
  • Drug: Placebo
    • 200 mg of Placebo administered twice daily

Arms, Groups and Cohorts

  • Active Comparator: Aspirin
    • 325 mg tablet, once daily for 5 days (Day -5 to -1)
  • Experimental: BMS-986177 plus aspirin
    • 200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7)
  • Placebo Comparator: Placebo plus aspirin
    • 200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7)

Clinical Trial Outcome Measures

Primary 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)
    • Time Frame: 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)
    • Time Frame: Up to 10 days
    • Measured by electrocardiogram (ECG)
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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