Clinical Trial

Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
notable Sponsor changed: SpringWorks Therapeutics, Inc. -> SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany 2026-05-09
Trial Details
NCT Number NCT06997276
Lead Sponsor SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Conditions Healthy, Hepatic Impairment
Enrollment 32 participants
Start Date 2025-05-07
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-03