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A Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Liver Impairment - IM025-015

Updated: 22 October, 2020   |   ClinicalTrials.gov

Print Friendly Summary

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


  • Gender(s)

  • 18-75

    Age Range

  • 1


  • Recruiting

Treatment Options

Study Arms
Experimental: Group A: Mild Hepatic Impairment
Drug: BMS-986263
Experimental: Group B: Moderate Hepatic Impairment
Drug: BMS-986263
Experimental: Group C: Severe Hepatic Impairment
Drug: BMS-986263
Experimental: Group D: Normal Hepatic function (control group)
Drug: BMS-986263
Experimental: Group E: Normal Hepatic Function (optional, control group)

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - BMI ≥ 18 kg/m^2 and weight ≥ 50 kg at screening (BMI = weight [kg]/height [m^2]). - Participants with normal hepatic function as judged by the investigator - Participants with hepatic impairment as judged by the investigator 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. - Any major surgery within 4 weeks of study drug administration - Previous exposure to BMS-986263 Other protocol-defined inclusion/exclusion criteria apply.

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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