Hepatic ImpairmentPhase 1NCT06535399
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 study testing BMS-986369 in people with Hepatic Impairment and Healthy Volunteers, run by Celgene at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy Volunteers
- What is being tested?
- BMS-986369
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Aug 2024to 12 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Local Institution - 0001
Chandler, Arizona, 85225
Local Institution - 0002
Orlando, Florida, 32809
Texas Liver Institute
San Antonio, Texas, 78215
About this study
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
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
- Being tested
- BMS-986369
- Keywords
- Healthy Volunteers, Pharmacokinetics, Liver Diseases, Moderate and Severe Hepatic Impairment, BMS-986369, CC-99282, Hepatic Impairment, Golcadomide
- Medical subject headings
- Liver Diseases, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986369Drug
Also called Golcadomide
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Group A: BMS-986369 Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: BMS-986369 |
| Group B: BMS-986369 Severe Hepatic Impairment | Experimental | Not described Receives: Drug: BMS-986369 |
| Group C: BMS-986369 Normal Hepatic Function | Experimental | Not described Receives: Drug: BMS-986369 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to approximately 44 days
Time of maximum observed plasma concentration (Tmax)
Measured: Up to approximately 44 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Measured: Up to approximately 44 days
Secondary outcomes (6)
Incidence of adverse events (AEs)
Measured: Up to approximately 44 days
Incidence of serious adverse events (SAEs)
Measured: Up to approximately 44 days
Number of participants with physical examination abnormalities
Measured: Up to approximately 44 days
Number of participants with vital sign abnormalities
Measured: Up to approximately 44 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to approximately 44 days
Number of participants with clinical safety laboratory test abnormalities
Measured: Up to approximately 44 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start15 Aug 2024
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535399
- Sponsor's protocol ID
- CA073-1028
- Status last verified
- Jan 2026
- First submitted
- 30 Jul 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06535399
- Acronym / sponsor ID
- CA073-1028
- Conditions
- Hepatic Impairment, Healthy Volunteers
- Keywords
- Healthy Volunteers, Pharmacokinetics, Liver Diseases, Moderate and Severe Hepatic Impairment, BMS-986369, CC-99282, Hepatic Impairment, Golcadomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: BMS-986369 Moderate Hepatic Impairment | Experimental | Drug: BMS-986369 |
| Group B: BMS-986369 Severe Hepatic Impairment | Experimental | Drug: BMS-986369 |
| Group C: BMS-986369 Normal Hepatic Function | Experimental | Drug: BMS-986369 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986369Also: GolcadomideSpecified dose on specified days | Drug | Group A: BMS-986369 Moderate Hepatic Impairment, Group B: BMS-986369 Severe Hepatic Impairment, Group C: BMS-986369 Normal Hepatic Function |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to approximately 44 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to approximately 44 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to approximately 44 days
6 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to approximately 44 days
Incidence of serious adverse events (SAEs)
Time frame: Up to approximately 44 days
Number of participants with physical examination abnormalities
Time frame: Up to approximately 44 days
Number of participants with vital sign abnormalities
Time frame: Up to approximately 44 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to approximately 44 days
Number of participants with clinical safety laboratory test abnormalities
Time frame: Up to approximately 44 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986369 in people with Hepatic Impairment and Healthy Volunteers, run by Celgene at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Up to approximately 44 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.