Trials / Terminated
TerminatedNCT05209295
A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies
A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics of CC-486 (Onureg®) in Subjects With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Adult Subjects With Myeloid Malignancies
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Onureg | Specified dose on specified days |
Timeline
- Start date
- 2024-07-12
- Primary completion
- 2025-04-20
- Completion
- 2025-04-20
- First posted
- 2022-01-26
- Last updated
- 2026-01-12
Locations
18 sites across 5 countries: United States, Argentina, Colombia, Germany, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05209295. Inclusion in this directory is not an endorsement.