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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: BMS-986263

Study type: Interventional

Funder types: Industry

Identifiers

NCT04225936

IM025-015

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

Group A: Mild Hepatic Impairment

Experimental group

Description:

Part 1

Treatment:

Drug: BMS-986263

Group B: Moderate Hepatic Impairment

Experimental group

Description:

Part 1

Treatment:

Drug: BMS-986263

Group C: Severe Hepatic Impairment

Experimental group

Description:

Part 2

Treatment:

Drug: BMS-986263

Group D: Normal Hepatic function (control group)

Experimental group

Description:

Part 1

Treatment:

Drug: BMS-986263

Group E: Normal Hepatic Function (optional, control group)

Experimental group

Description:

Part 2

Treatment:

Drug: BMS-986263