drugset / Trial / NCT05599932
Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child Pugh classification) on the plasma PK of siremadlin after a single oral dose. In addition, safety and tolerability of siremadlin after a single oral dose will be evaluated. The results of this study will inform the decision whether a dose adjustment may be recommended when treating patients with various degrees of impaired hepatic function.
Timeline
- Start
- 2022-12-02
- Primary completion
- 2023-09-18
- Completion
- 2023-09-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Siremadlin | Small molecule | — | Oral |