Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07279233 | To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants | PHASE1 | COMPLETED | 36 | — | — | Dec 15, 2025 | Feb 27, 2026 | May 8, 2026 | 1 | United States |
| NCT06997276 | Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib | PHASE1 | RECRUITING | 32 | — | — | May 7, 2025 | Sep 1, 2026 | May 8, 2026 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Period 1 Mirdametinib | ACTIVE_COMPARATOR | Mirdametinib 6-mg single dose given orally alone on Day 1 as three 2-mg capsules following a 10-hour fast. |
| Period 2 Mirdametinib and carbamazepine | EXPERIMENTAL | 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) |
| Moderate Hepatic Impairment | OTHER | - |
| Healthy Match Participants | OTHER | - |
| Severe Hepatic Impairment | OTHER | - |
| Name | Type | Description |
|---|---|---|
| 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 \[100 mg BID for 2 days, 200 mg BID for 2 days, and then 300 mg BID\]). |
| Mirdametinib (MEK Inhibitor) | DRUG | Mirdametinib will be administered as a single, oral, 4 mg dose in the morning on Day 1 for each study participant enrolled in the study. |
Inclusion Criteria: 1. Participant must sign the informed consent form (ICF) prior to any study-related procedures being performed. 2. Participant is male or female and between 18 and 65 years of age (inclusive) at the time of informed consent. 3. Participant has a body mass index (BMI) ≥18 and ≤32...