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A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants - IM011-087

Actualizada: 12 August, 2019   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1


  • Géneros

  • 18-50

    Rango de edad

  • 1

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
Experimental: Combination Therapy
Drug: Ritonavir Drug: BMS-986165

Criterios clave de elegibilidad

Inclusion Criteria: - Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.732 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula. - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic onadotropin) within 24 hours prior to the start of study treatment. - Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening. Exclusion Criteria: - Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1. - Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population. - Prisoners or participants who are involuntarily incarcerated - Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease

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