Facebook Icon Print Created with Sketch. Twitter Icon Created with Sketch. Created with Sketch. LinkedIn Icon Green Check Icon Created with Sketch. YouTube Icon Right Arrow Icon Mobile Menu Icon Chevron Right Icon Phone Icon Health Study Area: AutoImmune Disease Health Study Area: Blood Cancer Health Study Area: Cardiovascular Disease Health Study Area: Fibrosis Health Study Area: Gastrointestinal Cancer Health Study Area: Genitourinary Health Study Area: Head and Neck Cancer Health Study Area: Lung Cancer Health Study Area: Melanoma Health Study Area: Women's Cancer For Caregivers For Clinicians Communities FAQs For Parents For Patients Chevron Icon Bookmark Icon Map Icon Share Icon Direction Arrow Icon Direction Arrow Icon Page Icon Location Icon Search Icon External Link Icon Help Icon Error Icon Glossary Email Icon Gender Both Gender Male Gender Female Created with Sketch. Created with Sketch.

Inicie sesión o únase ahora para utilizar esta función

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: 29 July, 2019   |   ClinicalTrials.gov

Imprimir Resumen

Imprima esta página y la guía del estudio para poder hablar mejor con su médico.
Use la guía de estudios para explorar el proceso de participación en un estudio clínico. Comprenda qué factores clave debe considerar antes de decidirse y piense preguntas para hacerle a su equipo de atención médica.

Detalles del estudio

  • Phase 1


  • Géneros

  • 18-70

    Rango de edad

  • Active, Not Recruiting

Opciones de tratamiento

Brazos del estudio
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

¿Tiene alguna pregunta? Envíenos un correo electrónico

¿Tiene alguna pregunta?
Envíenos un correo electrónico