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Liver impairment drug study completed: how golcadomide behaves

NCT ID NCT06535399

Knowledge-focused Sponsor: Celgene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 study looked at how the drug golcadomide is processed in the body of people with moderate or severe liver impairment compared to healthy volunteers. 29 adults received a single dose, and researchers measured drug levels and safety. The goal is to understand if liver problems change how the drug works, which could guide future dosing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
golcadomide (BMS-986369)
What this could lead to
If successful, this study could help determine safe dosing of golcadomide for people with liver problems.
What could go wrong
This is a very early (Phase 1) study with only 29 participants, so results may not apply broadly. The drug may still have safety issues or not work as expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

29 people

The number who actually took part.

Started

Aug 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

follicular lymphoma liver disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers Hepatic impairment

Contacts and locations

Locations

  • 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

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