drugset
drugset / Trial / NCT06997276

Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

NCT06997276 ↗

Phase 1 Recruiting 32 enrolled SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Non-randomizedSequentialOpen-labelBasic science

Summary

The purposes of this study are to determine: * The pharmacokinetics (the amount of study drug in your blood and how long it takes the body to get rid of it) of the study drug and its metabolites (substances produced as the body breaks down the study drug) in participants with moderate or severe liver function impairment compared to participants with normal liver function (also known as a healthy volunteer). Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug. * How well the study drug is tolerated and any side effects that may occur in participants with moderate or severe liver function impairment compared to participants with normal liver function. This study is for research purposes only and is not intended to treat any medical condition.

Timeline

Start
2025-05-07
Primary completion
2026-09-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Mirdametinib Small molecule 4 mg Oral

Indications

No indication recorded.