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Recruiting

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

Actualizada: 14 January, 2019   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-55

    Rango de edad

  • 1

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
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: BMS-986177 Drug: Aspirin
Experimental: BMS-986177 + Aspirin + Clopidogrel
Drug: BMS-986177 Drug: Aspirin Drug: Clopidogrel
Experimental: BMS-986177 + Clopidogrel
Drug: BMS-986177 Drug: Clopidogrel
Placebo Comparator: BMS-986177 placebo + Aspirin
Drug: Aspirin Drug: Placebo (for BMS-986177)
Placebo Comparator: BMS-986177 placebo + Aspirin + Clopidogrel
Drug: Clopidogrel Drug: Placebo (for BMS-986177) Drug: Aspirin
Placebo Comparator: BMS-986177 placebo + Clopidogrel
Drug: Clopidogrel Drug: Placebo (for BMS-986177)

Criterios clave de elegibilidad

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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