Carbamazepine Effects on Mirdametinib
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how carbamazepine affects the levels and processing time of mirdametinib in the body. Mirdametinib treats various conditions, and this study aims to clarify its interaction with carbamazepine. Participants will take these medications orally and must be in good health, with no recent serious illnesses or infections. Healthy individuals with normal kidney function who can handle blood draws are ideal candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, allowing participants to contribute to early-stage medical research.
Will I have to stop taking my current medications?
Yes, participants must stop taking any prescription medications, over-the-counter medications, supplements, or herbal products at least 28 days before the study starts.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mirdametinib, the treatment in this trial, is generally well-tolerated. The FDA has already approved it for use in adults, indicating its safety for other conditions. However, mirdametinib can interact with other medications. There are 12 known drug interactions, with two classified as major and the rest as moderate.
Studies indicate that when combined with carbamazepine, carbamazepine can affect how the body processes other drugs, often lowering their levels in the blood. While this does not directly raise safety concerns, it underscores the need to monitor drug interactions.
For those considering joining the trial, these findings suggest mirdametinib is generally safe, but potential drug interactions should be noted. Always discuss your specific situation with your healthcare provider.12345Why are researchers excited about this trial's treatments?
Mirdametinib is unique because it targets MEK1/2, a part of the MAPK pathway often involved in tumor growth, which distinguishes it from other treatments that might not focus on this pathway. Researchers are excited about combining Mirdametinib with carbamazepine because this combination could potentially enhance its efficacy or alter its metabolism, offering a new approach compared to standard therapies. This could lead to better outcomes or new insights into managing conditions like neurofibromatosis, where traditional treatments might not fully address the underlying biological mechanisms.
What evidence suggests that mirdametinib could be effective?
Research shows that mirdametinib targets certain proteins involved in cell growth, potentially aiding in cancer treatment. In this trial, participants will receive mirdametinib alone in one treatment arm and in combination with carbamazepine in another. Studies have found that when mirdametinib is taken with drugs like carbamazepine, which boosts certain liver enzymes, it can alter the amount of mirdametinib in the blood. This is important because drug interactions can affect efficacy or increase side effects. Other studies suggest that carbamazepine can lower the levels of similar drugs by accelerating their breakdown in the body. Understanding these interactions helps researchers use mirdametinib safely and effectively in treatments.12678
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.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Period 1
Participants receive a 6-mg single oral dose of mirdametinib followed by PK sampling for 168 hours
Period 2
Participants receive carbamazepine ER twice daily for 21 days with a titration schedule, and a 6-mg single dose of mirdametinib on Day 22
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
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)
Mirdametinib 6-mg single dose given orally alone on Day 1 as three 2-mg capsules following a 10-hour fast.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SpringWorks Therapeutics, Inc.
Lead Sponsor
Citations
To Assess the Enzyme Inducing Effects of Carbamazepine ...
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 ...
Carbamazepine/imatinib | Reactions Weekly
It was concluded that the interaction of imatinib with carbamazepine, via CYP3A4 and P-gp strong induction, led to decrease in imatinib ...
Metabolism-related pharmacokinetic drug−drug interactions ...
The objective of this review is to highlight the current understanding of DDIs among TKIs, with a focus on metabolism, as well as to identify challenges.
Mirdametinib Interactions Checker
There are 12 drugs known to interact with mirdametinib, along with 4 disease interactions. Of the total drug interactions, 2 are major, and 10 are moderate.
5.
researchgate.net
researchgate.net/publication/7290350_Clinically_relevant_drug_interactions_with_antiepileptic_drugsClinically relevant drug interactions with antiepileptic drugs
Some patients with difficult-to-treat epilepsy benefit from combination therapy with two or more antiepileptic drugs (AEDs).
Mirdametinib, an FDA-Approved MEK1/2 inhibitor for adult ...
Key aspects discussed include mirdametinib's pharmacologic properties, clinical efficacy, safety profile, and comparison with other MEK ...
Mirdametinib: Uses, Interactions, Mechanism of Action
The risk or severity of Thrombosis can be increased when Peginesatide is combined with Mirdametinib.
8.
researchgate.net
researchgate.net/publication/11794128_Drug-drug_interaction_studies_with_mirtazapine_and_carbamazepine_in_healthy_male_subjectsDrug-drug interaction studies with mirtazapine and ...
In a study of healthy subjects, co-administration with carbamazepine, 200 mg twice a day for 32 days, was found to decrease by approximately 20% ...
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