Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

Phase 1

Recruiting

• Conditions: Healthy; Hepatic Impairment
• Interventions: Drug: Mirdametinib (MEK Inhibitor)

• Registration Number: NCT06997276
• Lead Sponsor: SpringWorks Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study Start: 2025-05-07
• Study First Submitted QC: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Submitted: 2025-05-30
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Moderate Hepatic Impairment	Mirdametinib (MEK Inhibitor)	-
Healthy Match Participants	Mirdametinib (MEK Inhibitor)	-
Severe Hepatic Impairment	Mirdametinib (MEK Inhibitor)	-

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of mirdametinib	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.
Time of maximum observed concentration (Tmax) of mirdametinib	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.
Area under the concentration-time curve from dosing extrapolated to infinity (AUC0-inf) of mirdametinib	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.
Area under the concentration-time curve from dosing to time of last quantifiable concentration (AUClast) of mirdametinib	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.

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability of mirdametinib	Assessments: AEs at Screening up to 32 days post-dose. Clinical laboratory tests at Screening, D-1, and D8/end of treatment (ET). ECGs at Screening, D-1, or D8/ET. Vital signs at Screening, D-1, D1, and D8/ET. PEs at Screening, D-1, and Day8/ET.	Adverse events (AEs), clinical laboratory tests, 12-lead electrocardiograms (ECGs), vital signs, and physical examinations (PEs) will be assessed.
Time of maximum observed concentration (Tmax) of PD-0315209	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.
Area under the concentration-time curve from dosing extrapolated to infinity (AUC0-inf) of PD-0315209	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.
Area under the concentration-time curve from dosing to time of last quantifiable concentration (AUClast) of PD-0315209	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.
Maximum plasma concentration (Cmax) of PD-0315209	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.

Trial Locations

Locations (2)

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States