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Active, Not Recruiting

An Investigational Study to Evaluate Experimental Medication BMS-986165 in Participants With Normal Kidney Function and Participants With Mild, Moderate, and Severe Kidney Damage and in Participants With End-Stage Kidney Disease on Dialysis - IM011-061

Actualizada: 25 March, 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: End-stage renal disease requiring dialysis
Drug: BMS-986165
Experimental: Mild renal disease
Drug: BMS-986165
Experimental: Moderate renal failure
Drug: BMS-986165
Experimental: Normal renal function
Drug: BMS-986165
Experimental: Severe renal failure
Drug: BMS-986165

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants must be judged to be in good health in the opinion of the investigator OR participant has a stable disease (eg, hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control (ie, no changes in medication within 30 days prior to study drug administration) - Stable renal impairment, defined as no clinically significant change in disease status, as documented by the participant's most recent eGFR assessment; eGFR must not vary more than 30% from screening to Day -1 to confirm stable renal function, and the renal impairment must be expected by the investigator not to change significantly during the next 3 months - Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥50 kg, at screening 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 - Have a history of cancer (malignancy) with the following exceptions: (1) subjects with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) subjects with other malignancies that 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 - History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening Other protocol defined inclusion/exclusion criteria could apply

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Llame 855-907-3286 o Envíenos un correo electrónico