NCT06997276

Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

A Phase 1 Open-Label Study to Assess the Pharmacokinetics of Mirdametinib and Its Metabolite PD-0315209 in Participants With Impaired Hepatic Function and Participants With Normal Hepatic Function

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: SpringWorks Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Mirdametinib (MEK Inhibitor)	Mirdametinib will be administered as a single, oral, 4 mg dose in the morning on Day 1 for each study participant enrolled in the study.

Timeline

• Start date: 2025-05-07
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-05-30
• Last updated: 2026-04-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study