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Recruiting

Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165 - IM011-088

Actualizada: 26 April, 2019   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-50

    Rango de edad

  • 1

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: BMS-986165 only
Drug: BMS-986165
Experimental: BMS-986165+Fluvoxamine
Drug: BMS-986165 Drug: Fluvoxamine
Experimental: Fluvoxamine only
Drug: Fluvoxamine

Criterios clave de elegibilidad

Inclusion Criteria: - Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator. - Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening. - Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula. Exclusion Criteria: - Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, - Any major surgery within 4 weeks of study drug administration - Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

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