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Active, Not Recruiting

A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease. - IM011-061

Updated: 29 July, 2019   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-70

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
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

Key Eligibility Criteria

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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