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Recruiting

A Study to Assess Administration of an Oral Anti-thrombotic With Antiplatelet Therapy in Healthy Subjects - CV010-034

Updated: 14 January, 2019   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-55

    Age Range

  • 1

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: BMS-986177 (Part 1)
Drug: BMS-986177
Experimental: BMS-986177 (Part 2)
Drug: BMS-986177
Experimental: BMS-986177 (Part 3)
Drug: BMS-986177
Experimental: BMS-986177 + Aspirin
Drug: Aspirin Drug: BMS-986177
Experimental: BMS-986177 + Aspirin + Clopidogrel
Drug: Clopidogrel Drug: Aspirin Drug: BMS-986177
Experimental: BMS-986177 + Clopidogrel
Drug: Clopidogrel Drug: BMS-986177
Placebo Comparator: BMS-986177 placebo + Aspirin
Drug: Placebo (for BMS-986177) Drug: Aspirin
Placebo Comparator: BMS-986177 placebo + Aspirin + Clopidogrel
Drug: Placebo (for BMS-986177) Drug: Clopidogrel Drug: Aspirin
Placebo Comparator: BMS-986177 placebo + Clopidogrel
Drug: Placebo (for BMS-986177) Drug: Clopidogrel

Key Eligibility Criteria

Inclusion Criteria: - Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive. - Women not of childbearing potential (must have documented proof). - Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986177 for a total of 92 days after completion of study treatment. Male participants must additionally refrain from sperm donation during this time. Exclusion Criteria: - Women of childbearing potential or who are breastfeeding. - Any significant acute or chronic medical illness, including tinnitus or any other condition listed as a contraindication in the aspirin package insert. - History of dizziness and/or recurrent headaches (i.e. daily headaches lasting for 1 week's duration in the last month prior to study treatment administration). - History of head injury in the last 2 years, including participants with base skull fractures, intracranial tumor, or aneurysm. - History of gastroesophageal reflux disease, dyspepsia (indigestion), protracted nausea, or chronic diarrhea (defined as 3 or 4 loose stools per day that last for ≥ 4 weeks) within the past 6 months. - Any major surgery within 4 weeks of study treatment administration or planned within 2 weeks after completion of the study. - 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 any adverse reaction to anticoagulants or antiplatelet agents that resulted in excessive bleeding, requiring medication intervention. Other protocol-defined inclusion/exclusion criteria could apply.

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