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

NCT03341390 | Completed Phase 1 FDA Drug

• 1 other identifier: CV010-027
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Volunteers

Keywords

Healthy participants; Healthy subjects; Strokes

Outcome Measures

Primary Outcomes (5)

• 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)

  Safety and tolerability of multiple doses of BMS-986177 measured by investigator assessment

  Up to 10 days

• Number of potential clinically significant changes in electrical activity of the heart in participants coadministered BMS-986177 (twice daily) and aspirin (once daily)

  Measured by electrocardiogram (ECG)

  Up to 10 days

• Number of participants with vital sign abnormalities.

  Up to 10 days

• Number of participants with physical examination abnormalities.

  Up to 10 days

• Number of participants with clinical laboratory abnormalities.

  Up to 10 days

Study Arms (3)

Aspirin

ACTIVE COMPARATOR

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

Drug: Aspirin

BMS-986177 plus aspirin

EXPERIMENTAL

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

Drug: Aspirin; Drug: BMS-986177

Placebo plus aspirin

PLACEBO COMPARATOR

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

Drug: Aspirin; Drug: Placebo

Interventions

Aspirin DRUG

1 x 325 mg tablet of aspirin administered once daily

Also known as: Acetylsalicylic Acid

Aspirin; BMS-986177 plus aspirin; Placebo plus aspirin

BMS-986177 DRUG

200 mg of BMS-986177 administered twice daily

BMS-986177 plus aspirin

Placebo DRUG

200 mg of Placebo administered twice daily

Placebo plus aspirin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Austin Clinic

Austin, Texas, 78744, United States

Location

Related Links

• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

MeSH Terms

Conditions

Stroke

Interventions

Aspirin; milvexian

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 14, 2017
• Study Start: October 18, 2017
• Primary Completion: November 16, 2017
• Study Completion: November 16, 2017
• Last Updated: January 19, 2018

Record last verified: 2018-01

Locations

US (1)