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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Study ID
NCT07279233
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Mirdametinib — DRUG
    6-mg single dose given orally on Day 1
  • Mirdametinib and Carbamazepine — DRUG
    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 \[100 mg BID for 2 days, 200 mg BID for 2 days, and then 300 mg BID\]).

Study Details

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.

Key Dates

First listed
Dec 12, 2025
Start date
Dec 15, 2025
Status verified
Mar 2026
Primary completion
Feb 27, 2026
Completion
Feb 27, 2026

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Period 1 Mirdametinib
    Mirdametinib 6-mg single dose given orally alone on Day 1 as three 2-mg capsules following a 10-hour fast.
  • Experimental: Period 2 Mirdametinib and carbamazepine
    Mirdametinib 6-mg single dose given orally on Day 22 in Period 2 as three 2-mg capsules following a 10-hour fast in combination with carbamazepine tablets that are administered orally according to the following schedule: * Days 8 and 9: 100 mg BID with meals * Days 10 and 11: 200 mg BID with meals * Days 12 through 21: 300 mg BID with meals * Day 22: 300 mg AM fasted, with mirdametinib, and 300 mg PM with meal * Days 23 through 28: 300 mg BID with meals * Days 29 through 30: no doses (observation only)

Primary Outcome Measure

The geometric mean ratio of mirdametinib plasma area under the concentration-time curve from dosing extrapolated to infinity (AUCinf) of Mirdametinib [ Time Frame: Day 1 to Day 29 ]

Locations (1)

FacilityCityStateZIPSite coordinators
MedpaceCincinnatiOhio45227-

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By research site
Medpace· Cincinnati, OH

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