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Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

NCT06997276 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997276 on ClinicalTrials.gov