Assessing the safety and drug levels of golcadomide in people with liver impairment and healthy volunteers
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
This study is testing how safe the drug golcadomide is and how it works in people with liver problems compared to healthy volunteers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Celgene Industry-sponsored |
| Locations | 6 sites (Chandler, Arizona and 5 other locations) |
| Trial ID | NCT06535399 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and pharmacokinetics of golcadomide (BMS-986369) in adult participants with moderate and severe hepatic impairment, alongside matched healthy volunteers. Participants will be grouped based on their liver function, with those having moderate or severe impairment being compared to healthy controls. The study aims to gather data on how the drug behaves in the body under different liver conditions. This phase 1 interventional study will help establish safety profiles and appropriate dosing for future research.
Who should consider this trial
Good fit: Ideal candidates include adults with moderate to severe hepatic impairment or healthy volunteers with normal liver function.
Not a fit: Patients with mild hepatic impairment or those with significant comorbid conditions that could interfere with the study may not benefit.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safe use of golcadomide for patients with liver impairment.
How similar studies have performed: Other studies assessing drug safety in hepatic impairment have shown promise, but this specific approach with golcadomide is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for all Participants (Group A, Group B, Group C): * Body mass index (BMI) between 18 and 40 kg/m\^2 (inclusive), and body weight ≥ 50 kg. Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group A and Group B): * Participants have moderate HI (Group A), severe HI (Group B) or cirrhosis due to chronic hepatic disease and/or prior alcohol use. * Participants have moderate (Group A) or severe (Group B) HI as defined by National Cancer Institute-Organ Dysfunction Working Group (NCI-ODWG) criteria. Inclusion Criteria for a Matched Healthy Participant (Group C): * Participants must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions as agreed by the investigator and the Sponsor Medical Monitor. * Participants must be free of any clinically significant disease that would interfere with the study evaluations. Exclusion Criteria for all Participants (Group A, Group B, and Group C): * Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME). * History of major surgery within 8 weeks before the study intervention administration. * Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, as determined by the investigator. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Chandler, Arizona and 5 other locations
- Arizona Liver Health — Chandler, Arizona, United States (Recruiting)
- Local Institution - 0004 — Chandler, Arizona, United States (Withdrawn)
- Local Institution - 0005 — Orlando, Florida, United States (Withdrawn)
- Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
- Local Institution - 0006 — San Antonio, Texas, United States (Withdrawn)
- Texas Liver Institute — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.