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

Phase 1

Recruiting

• Conditions: Hepatic Impairment; Healthy Volunteers
• Interventions: Drug: BMS-986369

• Registration Number: NCT06535399
• Lead Sponsor: Celgene

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Study First Posted: 2024-08-02
• Study Start: 2024-08-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-10-11
• Study Completion: 2025-10-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: BMS-986369 Moderate Hepatic Impairment	BMS-986369	-
Group B: BMS-986369 Severe Hepatic Impairment	BMS-986369	-
Group C: BMS-986369 Normal Hepatic Function	BMS-986369	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Up to approximately 44 days
Time of maximum observed plasma concentration (Tmax)	Up to approximately 44 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]	Up to approximately 44 days

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	Up to approximately 44 days
Incidence of serious adverse events (SAEs)	Up to approximately 44 days
Number of participants with physical examination abnormalities	Up to approximately 44 days
Number of participants with vital sign abnormalities	Up to approximately 44 days
Number of participants with electrocardiogram (ECG) abnormalities	Up to approximately 44 days
Number of participants with clinical safety laboratory test abnormalities	Up to approximately 44 days

Trial Locations

Locations (6)

Arizona Liver Health; 🇺🇸 Chandler, Arizona, United States

Local Institution - 0004; 🇺🇸 Chandler, Arizona, United States

Local Institution - 0005; 🇺🇸 Orlando, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Local Institution - 0006; 🇺🇸 San Antonio, Texas, United States

Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States