Last reviewed · How we verify
NCT05209295
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
Phase 1 trial testing Onureg in Hepatic Insufficiency in 2 participants. Terminated before completion.
20 April 2025
Quick facts
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 2 |
| Start date | 12 July 2024 |
| Primary completion | 20 April 2025 |
| Estimated completion | 20 April 2025 |
| Sites | 18 locations across Colombia, Germany, Argentina, United States, Spain |
Drugs / interventions tested
- Onureg — full drug profile →
Conditions studied
- Hepatic Insufficiency — all drugs for Hepatic Insufficiency →
- Neoplasms — all drugs for Neoplasms →
Sponsor
Bristol-Myers Squibb — full company profile →
Who can join
18 and older, any sex, with Hepatic Insufficiency or Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05209295
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Onureg
Trials testing the same drug.
- NCT06326697 — Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML) · Phase 1 · completed
Other recruiting trials for Hepatic Insufficiency
Currently open trials in the same condition.
- NCT06957756 — A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
Other Bristol-Myers Squibb trials
Trials by the same sponsor.
- NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
- NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
- NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
- NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
- NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05209295 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
- Last refreshed: 12 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05209295.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing