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Active, Not Recruiting

An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild, Moderate and Severe Liver Damage - IM011-062

Actualizada: 12 noviembre, 2019   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-70

    Rango de edad

  • Active, Not Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Mild liver impairment
Drug: BMS-986165
Experimental: Moderate liver impairment
Drug: BMS-986165
Experimental: Normal liver function
Drug: BMS-986165
Experimental: Severe liver impairment
Drug: BMS-986165

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening - Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.73 m2 for participants Exclusion Criteria: - Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant - History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening - Have a history of cancer (malignancy) with the following exceptions: (1) participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) participants with other malignancies who have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit Other protocol defined inclusion/exclusion criteria could apply

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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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