Carbamazepine Effects on Mirdametinib

Overseen By SpringWorks Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SpringWorks Therapeutics, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for healthy individuals who can safely take the medications mirdametinib and carbamazepine. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

What Are the Treatments Tested in This Trial?

Interventions

• Mirdametinib

Trial Overview The study is testing how the drug carbamazepine affects the blood levels and elimination of another drug, mirdametinib, when taken together by mouth. Participants will be observed over a period that could last up to about 64 days.

How Is the Trial Designed?

Group I: Period 2 Mirdametinib and carbamazepine Experimental Treatment 1 Intervention

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)

Group II: Period 1 Mirdametinib Active Control 1 Intervention

Mirdametinib 6-mg single dose given orally alone on Day 1 as three 2-mg capsules following a 10-hour fast.

Who Is Running the Clinical Trial?

SpringWorks Therapeutics, Inc.

Lead Sponsor

Trials

14

Recruited

900+