At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Open-label 4-way Crossover Study to Compare the PK, Safety, and Tolerability of M207 at Two Different Application Locations for 30 Minutes With Intranasal Zolmitriptan 2.5 mg and 1 Hour Wear Time in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating A: M207 3.8mg, 30 min, upper arm, B: M207 3.8 mg, 30 min, thigh, and 2 other interventions for Migraine. Completed, enrolled 24 participants across 1 site.
Detailed Summary
This is a single-center, open-label, randomized, four-way crossover study. Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis. Dosing will occur approximately 48 hours apart, until completion of dosing in randomized order per the treatment sequence tables. Plasma samples from the dosing days will be sent to the analytical laboratory for analysis and tolerability for each of the dose levels will be summarized. After completion of the four dosing days, subjects will be assessed one final time and dismissed from the study.
Study Details
Timeline
Interventions
A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
D: 2.5 mg/0.1 mL intranasal zolmitriptan