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CompletedNCT03341390Updated Jan 19, 2018

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

A Phase 1 interventional study of Aspirin and BMS-986177 in Healthy Volunteers, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-19.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Nov 2017, 8 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers

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Keywords

  • Healthy participants
  • Healthy subjects
  • Strokes
03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Aspirin

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

    Drug: Aspirin

  • Experimental
    BMS-986177 plus aspirin

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

    Drug: Aspirin · Drug: BMS-986177

  • Placebo comparator
    Placebo plus aspirin

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

    Drug: Aspirin · Drug: Placebo

Interventions

  • 1 x 325 mg tablet of aspirin administered once daily

    Also known as: Acetylsalicylic Acid

  • 200 mg of BMS-986177 administered twice daily

  • DrugPlacebo

    200 mg of Placebo administered twice daily

06

What researchers measure

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)

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

    Time frame: Up to 10 days

  2. 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)

    Time frame: Up to 10 days

  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

07

Study locations

1 site
  • PPD Austin Clinic
    Austin, Texas 78744, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03341390
Responsible party
Sponsor
First posted
Nov 14, 2017
Start date
Oct 18, 2017
Primary completion
Nov 16, 2017
Completion
Nov 16, 2017
Last update
Jan 19, 2018

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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