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Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Sep 30, 2026 → Oct 31, 2026
See other at-risk trials from SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date moved earlier from May 7, 2025 to Apr 24, 2025
  2. Eligibility criteria expanded, about 52 words
    • Secondary endpoints: details revised at 1 of 5 entries
  3. Primary and study completion pushed from Sep 30, 2026 to Oct 31, 2026v8
  4. Re-verified, no change to tracked fieldsv7
  5. Study Status, IPDSharing, Referencesv6
  6. Primary and study completion dates: Sep 2026 to Sep 30, 2026
    • Site details revised at 3 of 3 sites
    v5
  7. Sponsor changed: SpringWorks Therapeutics, Inc. to SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germanyv4
  8. Study sites: 2 to 3
    • Primary and study completion dates: Jul 2026 to Sep 2026
    v3
  9. Re-verified, no change to tracked fieldsv2
  10. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06997276
Lead Sponsor SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Conditions
(from sponsor)		 Healthy, Hepatic Impairment
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov