Finding studies
Finding studies
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Lead
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
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.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
