drugset / Trial / NCT07422610
Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary purpose of this study is to evaluate the impact of hepatic function on the pharmacokinetic (PK) profile of pelabresib in participants with advanced malignancies who have either hepatic impairment (HI) or normal liver function. To reduce participant burden and maximize benefit, the PK of pelabresib will be assessed at steady-state rather than after a single dose, avoiding treatment-free washout periods.
Timeline
- Start
- 2026-04-24
- Primary completion
- 2028-06-28
- Completion
- 2028-08-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pelabresib | Small molecule | 125 mg | Oral |
Indications
No indication recorded.