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COMPLETED
NCT07279233
PHASE1

To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants

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

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the effect of carbamazepine on the blood levels of mirdametinib and how long it takes the body to eliminate mirdametinib when both drugs are administered orally in healthy participants. The study may last up to approximately 64 days for each participant.

Official title: A Phase 1, Open-Label Study to Assess the Enzyme Inducing Effects of Carbamazepine on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-12-15

Completion Date

2026-02-27

Last Updated

2026-05-08

Healthy Volunteers

Yes

Interventions

DRUG

Mirdametinib

6-mg single dose given orally on Day 1

DRUG

Mirdametinib and Carbamazepine

Drug: Mirdametinib 6-mg single dose given orally on Day 22. Drug: Carbamazepine Carbamazepine extended-release (ER) (Carbamazepine ER will be given orally twice daily for 21 days with a titration schedule \[100 mg BID for 2 days, 200 mg BID for 2 days, and then 300 mg BID\]).

Locations (1)

Medpace

Cincinnati, Ohio, United States