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

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ClinicalTrials.gov Identifier: NCT03341390
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Aspirin Drug: BMS-986177 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : October 18, 2017
Actual Primary Completion Date : November 16, 2017
Actual Study Completion Date : November 16, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Aspirin
325 mg tablet, once daily for 5 days (Day -5 to -1)
Drug: Aspirin
1 x 325 mg tablet of aspirin administered once daily
Other Name: Acetylsalicylic Acid

Experimental: BMS-986177 plus aspirin
200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Drug: Aspirin
1 x 325 mg tablet of aspirin administered once daily
Other Name: Acetylsalicylic Acid

Drug: BMS-986177
200 mg of BMS-986177 administered twice daily

Placebo Comparator: Placebo plus aspirin
200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Drug: Aspirin
1 x 325 mg tablet of aspirin administered once daily
Other Name: Acetylsalicylic Acid

Drug: Placebo
200 mg of Placebo administered twice daily




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Other protocol-defined inclusion/exclusion criteria could apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341390


Locations
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United States, Texas
PPD Austin Clinic
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03341390     History of Changes
Other Study ID Numbers: CV010-027
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bristol-Myers Squibb:
Healthy participants
Healthy subjects
Strokes

Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics