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Completed

NCT Number: NCT03341390

An Investigational Study to Assess the Effect 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Austin Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin

Drug

1 x 325 mg tablet of aspirin administered once daily

Other names: Acetylsalicylic Acid

BMS-986177

Drug

200 mg of BMS-986177 administered twice daily

Placebo

Drug

200 mg of Placebo administered twice daily

Primary outcomes

  1. 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

  2. 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)

  3. Number of participants with vital sign abnormalities.

    Time frame: Up to 10 days

  4. Number of participants with physical examination abnormalities.

    Time frame: Up to 10 days

  5. Number of participants with clinical laboratory abnormalities.

    Time frame: Up to 10 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 14, 2017
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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