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Recruiting

A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function - CV013-025

Actualizada:   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-70

    Rango de edad

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Mild Renal Impairment
Drug: BMS-986231
Experimental: Moderate renal impairment
Drug: BMS-986231
Experimental: Normal renal function
Drug: BMS-986231
Experimental: Severe renal impairment
Drug: BMS-986231

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Body weight ≥ 45 kg and ≤ 120 kg - BMI ≥ 18 kg/m^2 and ≤ 35 kg/m^2 - Heart rate ≥ 50 bpm and < 95 bpm - Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment - No changes in medication within 30 days prior to study drug administration Exclusion Criteria: - Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests - History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months - History of headaches related to caffeine withdrawal - History of migraine or cluster headaches - Patients requiring dialysis will not be enrolled in this study Other protocol defined inclusion/exclusion criteria could apply

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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