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

NCT ID: NCT03341390

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-18
• Study Completion Date: 2017-11-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Aspirin

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

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

1 x 325 mg tablet of aspirin administered once daily

BMS-986177 plus aspirin

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

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

1 x 325 mg tablet of aspirin administered once daily

BMS-986177

Intervention Type: DRUG

200 mg of BMS-986177 administered twice daily

Placebo plus aspirin

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

Group Type: PLACEBO_COMPARATOR

Aspirin

Intervention Type: DRUG

1 x 325 mg tablet of aspirin administered once daily

Placebo

Intervention Type: DRUG

200 mg of Placebo administered twice daily

Interventions

Aspirin

1 x 325 mg tablet of aspirin administered once daily

Intervention Type: DRUG

BMS-986177

200 mg of BMS-986177 administered twice daily

Intervention Type: DRUG

Placebo

200 mg of Placebo administered twice daily

Intervention Type: DRUG

Other Intervention Names

Acetylsalicylic Acid

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

PPD Austin Clinic

Austin, Texas, United States

Countries

United States

Related Links

http://www.fda.gov/Safety/Recalls

FDA Safety Alerts and Recalls

http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx

Investigator Inquiry Form

Other Identifiers

CV010-027

Identifier Type: -

Identifier Source: org_study_id