NCT04634149

A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Normal Hepatic Function and Participants With Moderate and Severe Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.

Conditions

• Moderate Liver Impairment
• Severe Liver Impairment

Interventions

Type	Name	Description
DRUG	BMS-986036	Specified dose on specified days

Timeline

• Start date: 2020-11-23
• Primary completion: 2022-06-02
• Completion: 2022-06-02
• First posted: 2020-11-18
• Last updated: 2022-06-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study