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RECRUITING
NCT07840612
PHASE1

A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants

Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

This is a single-centre, open-label, fixed-sequence, 2-period study in healthy participants. The total study duration for each participant will be up to approximately 56 days, including a 28-day screening period, a 19-day assessment period (including Period 1 and Period 2), and a follow-up (FU) visit approximately 7 days after clinical research unit (CRU) discharge.

Official title: A Phase 1, Open-Label, Drug Interaction Study to Assess the Effects of Probenecid, a Probe UGT Enzyme Inhibitor, 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

17

Start Date

2026-09-25

Completion Date

2026-11-17

Last Updated

2026-10-09

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Mirdametinib

Mirdametinib capsules administered orally.

DRUG

Probenecid

Probenecid tablets administered orally.

Locations (1)

Nuvisan GmbH

Neu-Ulm, Germany