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

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263

Key facts

Study ID

NCT04225936

Run by

Bristol-Myers Squibb

People needed

40

Starts

2020-01-16

Expected to finish

2021-06-01

Last updated by the study team

2021-11-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Texas Liver Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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