NCT06535399

Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic Impairment

A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the drug levels and safety of golcadomide (BMS-986369) in adult participants with moderate and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.

Conditions

• Hepatic Impairment
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	BMS-986369	Specified dose on specified days

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-11-12
• Completion: 2025-11-12
• First posted: 2024-08-02
• Last updated: 2026-01-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study