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NCT06535399 · ClinicalTrials.gov registry record · Phase 1

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, sponsored by Celgene.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target

NCT06535399: Completed Phase 1 study, sponsored by Celgene.

NCT06535399 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06535399, a Phase 1 study, has completed, sponsored by Celgene.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study 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.

Interventions

  • DRUG BMS-986369

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2024-08-15
Est. Completion 2025-11-12
Phase Phase 1
Celgene

308 total trials

What the finished NCT06535399 record still lists

NCT06535399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 1 intervention - of which BMS-986369 is the first listed.

NCT06535399 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06535399 about?

NCT06535399 is a clinical study titled "Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of 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.

What is the current status of trial NCT06535399?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2024-08-15. Estimated completion is 2025-11-12.

What interventions are being tested in trial NCT06535399?

The interventions under investigation include: BMS-986369 (DRUG).

Who is sponsoring clinical trial NCT06535399?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06535399's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06535399, the US trial registry maintained by the National Library of Medicine. NCT06535399 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.