Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-21 @ 1:01 AM
Study NCT ID:
NCT07279233
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants
Sponsor:
SpringWorks Therapeutics, Inc.
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: