Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
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.
Key facts
- Study ID
- NCT05599932
- Run by
- Novartis Pharmaceuticals
- People needed
- 38
- Starts
- 2022-12-02
- Expected to finish
- 2023-09-18
- Last updated by the study team
- 2025-07-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
Where it is running
- Clinical Pharmacology of Miami LLC — Miami, Florida, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
- Texas Liver Institute — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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