HealthyPhase 1NCT07279233
To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants
A Phase 1 study testing Mirdametinib and Mirdametinib and Carbamazepine in people with Healthy and Volunteer, run by SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Mirdametinib and Mirdametinib and Carbamazepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 27 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must sign the informed consent form (ICF) prior to any study-related procedures being performed.
- Participant is male or female and between 18 and 65 years of age (inclusive) at the time of informed consent.
- Participant has a body mass index (BMI) ≥18 and ≤32 kg/m² (inclusive) at Screening and Day -1.
- Participant is in good health in the judgment of the investigator on the basis of a medical evaluation performed at Screening, Day -1, and predose on Day 1, and the results of clinical chemistry, hematology, coagulation, and urinalysis tests carried out at Screening and Day -1. Clinical laboratory test results within normal reference range for the population or investigative site, or results within acceptable deviations that are judged to be not clinically significant by the investigator.
- Note: Laboratory values that are out-of-range may be confirmed by a single repeat per investigator discretion.
- Participant has normal or mildly impaired renal function as estimated by the Chronic Kidney Disease Epidemiology Collaboration formula (i.e., ≥60 mL/min).
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- Participant has sufficiently good venous access in at least 1 arm to confidently enable serial blood sampling.
- Male participants who agree to the following during study and for at least 90 days after the last dose of study medication:
- Refrain from donating or preserving sperm, PLUS either
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR
- Must agree to use a male condom when having sexual intercourse with women of childbearing potential (WOCBP). An additional form of contraception should also be used by the female partner if she is of childbearing potential.
- Female participants that are not pregnant or breastfeeding, and for whom one of the following conditions applies:
- Is a woman of non-childbearing potential.
- Is a WOCBP and agrees to use an acceptable contraceptive method from the time of signed informed consent and for at least 6 weeks after the last dose of study medication; AND
- All female participants must have a negative serum pregnancy test at Screening and CRU admission (Day -1)
Who cannot join
- Participant has clinically significant infections (e.g., coronavirus disease 2019 [COVID-19] or influenza) within 90 days prior to Day 1, as judged by the investigator, or evidence of any infection within 14 days prior to Day 1. If a participant tests positive (reactive) for Hepatitis B, Hepatitis C, or HIV at Screening, they are not eligible for participation in the study.
- 2. Participant has a history of any neurological conditions including movement disorders and seizures.
- 3. Participant has a history of stomach or GI surgery or resection that would potentially alter absorption, metabolism, and/or excretion of PO administered drugs (exceptions include participants who underwent appendectomy or any type of hernia repair).
- 4. Participant has a history of pre-existing condition interfering with normal GI anatomy or motility and potentially alter the absorption, metabolism, and/or excretion of orally administered drugs.
- 5. Participants with a history of inflammatory bowel disease, peptic ulceration, or pancreatitis within 180 days prior to Day 1.
- 6. Participant has a history of cancer, except if judged to be in full remission for at least 5 years at the time of informed consent (except basal cell skin cancer, resected prostate cancer with an undetectable Prostate-Specific Antigen test (PSA), or squamous cell skin cancer with history of curative treatment and no recurrence for at least 3 years prior to Screening), as judged by the investigator.
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- 7. Participant has an acute illness with symptoms or treatment that has started or persisted within 14 days prior to Day 1 unless mild in severity and enrollment is approved by both the investigator and the sponsor's medical monitor.
- 8. Participant has any evidence of glaucoma or retinal vein occlusion, visual blurring or uncorrected vision issues, or intraocular pressure (IOP) >21 mmHg on Day -1.
- 9. Participant has cardiovascular abnormalities including:
- History of postural hypotension, unexplained syncope, or abnormal autonomic tone
- Blood pressure <90/50 mmHg or >140/90 mmHg after 5 minutes of rest
- Heart rate <45 or >100 bpm after 5 minutes of rest
- Abnormal QT interval corrected by Fridericia's formula (QTcF) interval (≥450 msec) or ECG abnormalities interfering with QT/QTc interpretation
- Risk factors for torsades de pointes
- Ejection fraction <55% 10. Participant has an acute illness, significant infection, or incomplete bladder emptying (voiding >2 times/night).
- 11. Participant has any clinically significant abnormality in hematology parameters at Screening or Day -1 as determined by the investigator.
- <!-- -->
- Participant has a hemoglobin < 11.0 g/dL for female participants or < 12.5 g/dL for male participants.
- Participant has a hematocrit < the lower limit of normal.
- Participant has a white blood cell count < the lower limit of normal.
- Participant has a platelet count < the lower limit of normal. 12. Participant has a history or evidence of any hematological disorder such as anemia, leukopenia, thrombocytopenia, or bleeding disorder.
- 13. Participant has any known or suspected hereditary blood disorder (e.g., sickle cell, or thalassemia).
- 14. Participant has alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin levels >1.5× the upper limit of normal at Screening or Day -1.
- 15. Participant has substance use concerns:
- <!-- -->
- Positive alcohol, cotinine, or drug screen test
- Alcohol intake >3 units/day or >14 units/week in past 6 months
- Excessive caffeine consumption (>400 mg/day)
- Tobacco or nicotine use within 3 months of Screening
- Unwillingness to avoid xanthine-containing products 72 hours before dosing 16. Participant has taken, received, or consumed:
- <!-- -->
- Any prescription medications, over-the-counter medications, supplements, or herbal products within 28 days or 5 half-lives if known (whichever is longer)
- Vaccines within 14 days prior to Day 1; live vaccines within 28 days prior to Day 1.c. Investigational products within 28 days or 5 half-lives, or >3 new investigational entities within 12 months
- Red wine, any fruit juices (including, but not limited to, grapefruit, grapefruit juice, pomelos, or other exotic citrus fruits, or grapefruit hybrids), or any nutrients known to modulate drug metabolizing enzyme/transporters activity (including, but not limited to, cranberries or star fruits) within 72 hours of Day -1 17. Participant has donated blood (>450 mL) within 60 days, donated plasma within 7 days, or received blood products within 60 days.
- 18. Participant is unwilling to avoid strenuous activity, sunbathing, or contact sports during the study.
- 19. Participant has a history of known prior major depression. 20. Participant has a significant risk of committing suicide based on medical history in the opinion of the investigator; or an answer of "Yes" to questions #4 or #5 of the Columbia-Suicide Severity Scale (C-SSRS; [Posner 2011]).
- 21. Participant has specific contraindications to the study medications:
- Known hypersensitivity to carbamazepine, mirdametinib, or related compounds b. Participant is Asian or has one or more Asian parents or grandparents c. History of anaphylaxis d. History of severe cutaneous adverse reactions (such as Stevens-Johnson Syndrome, toxic epidermal necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms).
- 22. Participant is deemed unsuitable for this study in the opinion of the investigator for any additional reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Assess the Enzyme Inducing Effects of Carbamazepine on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants
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.
Read the detailed description
This is a Phase 1, open-label, fixed-sequence, 2-period clinical study in healthy participants. Approximately 36 participants will be enrolled in the study to achieve 25 evaluable participants.
Healthy male and/or female participants, aged 18 to 65 years (inclusive), not of Asian descent, with body mass index (BMI) between 18 and 32 kg/m², and who are medically healthy with no clinically significant abnormalities.
The study consists of screening (28 days), 2 study periods, and a 7-day follow-up.
Mirdametinib will be given as a single 6-mg dose on 2 separate occasions: once on Day 1 and once on Day 22. Carbamazepine ER will be given twice daily for 21 days beginning on Day 8.
On Day 1 of Period 1, participants will receive a 6-mg single oral dose of mirdametinib followed by PK sampling for 168 hours (Day 8). In Period 2, participants will receive carbamazepine extended-release (ER) twice daily for 21 days with a titration schedule (100 mg twice daily [BID] for 2 days, 200 mg BID for 2 days, and 300 mg BID for the remaining days). On Day 22, participants will receive a 6-mg single dose of mirdametinib with the morning dose of carbamazepine ER, followed by PK sampling for 168 hours.
- Being tested
- Mirdametinib, Mirdametinib and Carbamazepine
- Keywords
- Drug interaction, Mirdametinib, Carbamazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirdametinibDrug
6-mg single dose given orally on Day 1
Mirdametinib and CarbamazepineDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Mirdametinib |
| 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) Receives: Drug: Mirdametinib and Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The geometric mean ratio of mirdametinib plasma area under the concentration-time curve from dosing extrapolated to infinity (AUCinf) of Mirdametinib
Measured: Day 1 to Day 29
The geometric mean ratio area under the concentration-time curve from dosing to time of last quantifiable concentration (AUClast) of Mirdametinib
Measured: Day 1 to Day 29
The geometric mean ratio of maximum observed concentration (Cmax) of Mirdametinib
Measured: Day 1 to Day 22
Secondary outcomes (11)
Number of participants who Experience an Adverse Event
Measured: Up to a maximum of 36 days
AUCinf of Metabolites M15, M22, and M30
Measured: Day 1 to Day 29
AUClast of Metabolites M15, M22, and M30
Measured: Day 1 to Day 29
Cmax of Metabolites M15, M22, and M30
Measured: Day 1 to Day 22
Time of maximum observed concentration (Tmax) of Mirdametinib and Metabolites M15, M22, and M30
Measured: Day 1 to Day 22
Apparent terminal elimination half-life (t1/2) of Mirdametinib and Metabolites M15, M22, and M30
Measured: Day 1 to Day 29
Apparent clearance (CL/F) of Mirdametinib and Metabolites M15, M22, and M30
Measured: Day 1 to Day 29
Apparent volume of distribution (Vd/F) of Mirdametinib and Metabolites M15, M22, and M30
Measured: Day 1 to Day 29
Metabolite to parent molar ratio AUCinf (MRAUCinf)
(AUCinf, metabolite/MWmetabolite)/(AUCinf, parent/MWparent)
Measured: Day 1 to Day 29
Metabolite to parent molar ratio AUClast (MRAUClast),
(AUClast, metabolite/MWmetabolite)/(AUClast, parent/MWparent)
Measured: Day 1 to Day 29
Metabolite to parent molar ratio Cmax (MRCmax)
(Cmax, metabolite/MWmetabolite)/(Cmax, parent/MWparent)
Measured: Day 1 to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start15 Dec 2025
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Fixed-sequence
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279233
- Sponsor's protocol ID
- MEK-NF1-105
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Assess the Enzyme Inducing Effects of Carbamazepine on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants
- ClinicalTrials.gov ID
- NCT07279233
- Acronym / sponsor ID
- MEK-NF1-105
- Keywords
- Drug interaction, Mirdametinib, Carbamazepine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, open-label, fixed-sequence, 2-period clinical study in healthy participants. Approximately 36 participants will be enrolled in the study to achieve 25 evaluable participants.
Healthy male and/or female participants, aged 18 to 65 years (inclusive), not of Asian descent, with body mass index (BMI) between 18 and 32 kg/m², and who are medically healthy with no clinically significant abnormalities.
The study consists of screening (28 days), 2 study periods, and a 7-day follow-up.
Mirdametinib will be given as a single 6-mg dose on 2 separate occasions: once on Day 1 and once on Day 22. Carbamazepine ER will be given twice daily for 21 days beginning on Day 8.
On Day 1 of Period 1, participants will receive a 6-mg single oral dose of mirdametinib followed by PK sampling for 168 hours (Day 8). In Period 2, participants will receive carbamazepine extended-release (ER) twice daily for 21 days with a titration schedule (100 mg twice daily [BID] for 2 days, 200 mg BID for 2 days, and 300 mg BID for the remaining days). On Day 22, participants will receive a 6-mg single dose of mirdametinib with the morning dose of carbamazepine ER, followed by PK sampling for 168 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Fixed-sequence
| Arm | Type | Receives |
|---|---|---|
| Period 1 Mirdametinib | Active comparator | Drug: MirdametinibMirdametinib 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 | Drug: Mirdametinib and CarbamazepineMirdametinib 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participant must sign the informed consent form (ICF) prior to any study-related procedures being performed.
- Participant is male or female and between 18 and 65 years of age (inclusive) at the time of informed consent.
- Participant has a body mass index (BMI) ≥18 and ≤32 kg/m² (inclusive) at Screening and Day -1.
- Participant is in good health in the judgment of the investigator on the basis of a medical evaluation performed at Screening, Day -1, and predose on Day 1, and the results of clinical chemistry, hematology, coagulation, and urinalysis tests carried out at Screening and Day -1. Clinical laboratory test results within normal reference range for the population or investigative site, or results within acceptable deviations that are judged to be not clinically significant by the investigator.
- Note: Laboratory values that are out-of-range may be confirmed by a single repeat per investigator discretion.
Key exclusion criteria (39 listed)
- Participant has clinically significant infections (e.g., coronavirus disease 2019 [COVID-19] or influenza) within 90 days prior to Day 1, as judged by the investigator, or evidence of any infection within 14 days prior to Day 1. If a participant tests positive (reactive) for Hepatitis B, Hepatitis C, or HIV at Screening, they are not eligible for participation in the study.
- 2. Participant has a history of any neurological conditions including movement disorders and seizures.
- 3. Participant has a history of stomach or GI surgery or resection that would potentially alter absorption, metabolism, and/or excretion of PO administered drugs (exceptions include participants who underwent appendectomy or any type of hernia repair).
- 4. Participant has a history of pre-existing condition interfering with normal GI anatomy or motility and potentially alter the absorption, metabolism, and/or excretion of orally administered drugs.
- 5. Participants with a history of inflammatory bowel disease, peptic ulceration, or pancreatitis within 180 days prior to Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirdametinib6-mg single dose given orally on Day 1 | Drug | Period 1 Mirdametinib |
| Mirdametinib and CarbamazepineDrug: 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]). | Drug | Period 2 Mirdametinib and carbamazepine |
Primary outcome
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
The geometric mean ratio area under the concentration-time curve from dosing to time of last quantifiable concentration (AUClast) of Mirdametinib
Time frame: Day 1 to Day 29
The geometric mean ratio of maximum observed concentration (Cmax) of Mirdametinib
Time frame: Day 1 to Day 22
11 secondary outcomes
Number of participants who Experience an Adverse Event
Time frame: Up to a maximum of 36 days
AUCinf of Metabolites M15, M22, and M30
Time frame: Day 1 to Day 29
AUClast of Metabolites M15, M22, and M30
Time frame: Day 1 to Day 29
Cmax of Metabolites M15, M22, and M30
Time frame: Day 1 to Day 22
Time of maximum observed concentration (Tmax) of Mirdametinib and Metabolites M15, M22, and M30
Time frame: Day 1 to Day 22
Apparent terminal elimination half-life (t1/2) of Mirdametinib and Metabolites M15, M22, and M30
Time frame: Day 1 to Day 29
Apparent clearance (CL/F) of Mirdametinib and Metabolites M15, M22, and M30
Time frame: Day 1 to Day 29
Apparent volume of distribution (Vd/F) of Mirdametinib and Metabolites M15, M22, and M30
Time frame: Day 1 to Day 29
Metabolite to parent molar ratio AUCinf (MRAUCinf)
Time frame: Day 1 to Day 29
Metabolite to parent molar ratio AUClast (MRAUClast),
Time frame: Day 1 to Day 29
Metabolite to parent molar ratio Cmax (MRCmax)
Time frame: Day 1 to Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mirdametinib and Mirdametinib and Carbamazepine in people with Healthy and Volunteer, run by SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.