COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-15
Study Completion:2025-11-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06535399

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0001
Chandler, Arizona, 85225
United States
Local Institution - 0002
Orlando, Florida, 32809
United States
Texas Liver Institute
San Antonio, Texas, 78215
United States

Collaborators and Investigators

Sponsor: Celgene

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-15
Study Completion Date2025-11-12

Study Record Updates

Study Start Date2024-08-15
Study Completion Date2025-11-12

Terms related to this study

Keywords Provided by Researchers

  • Healthy Volunteers
  • Pharmacokinetics
  • Liver Diseases
  • Moderate and Severe Hepatic Impairment
  • BMS-986369
  • CC-99282
  • Hepatic Impairment
  • Golcadomide

Additional Relevant MeSH Terms

  • Hepatic Impairment
  • Healthy Volunteers