To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Parti… (NCT07279233) | Clinical Trial Compass
CompletedPhase 1
To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants
United States36 participantsStarted 2025-12-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Participant has normal or mildly impaired renal function as estimated by the Chronic Kidney Disease Epidemiology Collaboration formula (i.e., ≥60 mL/min).
✓. 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
Exclusion criteria
✕. History of postural hypotension, unexplained syncope, or abnormal autonomic tone
✕
What they're measuring
1
The geometric mean ratio of mirdametinib plasma area under the concentration-time curve from dosing extrapolated to infinity (AUCinf) of Mirdametinib
Timeframe: Day 1 to Day 29
2
The geometric mean ratio area under the concentration-time curve from dosing to time of last quantifiable concentration (AUClast) of Mirdametinib
Timeframe: Day 1 to Day 29
3
The geometric mean ratio of maximum observed concentration (Cmax) of Mirdametinib
Timeframe: Day 1 to Day 22
Trial details
NCT IDNCT07279233
SponsorSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany