Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

Part of paid clinical trials in Miami, Florida.

Sponsor
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Study ID
NCT06997276
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Mirdametinib (MEK Inhibitor) — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 7, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Moderate Hepatic Impairment
  • Other: Healthy Match Participants
  • Other: Severe Hepatic Impairment

Primary Outcome Measure

Maximum plasma concentration (Cmax) of mirdametinib [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168-hours post dose. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of MiamiMiamiFlorida33014
Alexander Prezioso, MD
[email protected]
305-817-2900
Orlando Clinical Research CenterOrlandoFlorida32809
Thomas Marbury, MD
[email protected]
407-240-7876
American Research Corporation (Texas Liver Institute)San AntonioTexas78215-

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By research site
Clinical Pharmacology of Miami· Miami, FLOrlando Clinical Research Center· Orlando, FLAmerican Research Corporation (Texas Liver Institute)· San Antonio, TX

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