A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers

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.

This is a single-center, open-label, randomized, four-way crossover study to compare the pharmacokinetics, safety and tolerability of: M207 3.8 mg administered to the upper arm to M207 3.8 mg administered to the thigh, particularly with respect to skin irritation (erythema, edema, bruising, bleeding): M207 3.8 mg worn for 30 minutes on the upper arm to M207 3.8 mg worn for 1 hour on the upper arm; and M207 3.8 mg to intranasal zolmitriptan 2.5 mg. Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis. M207 application sites will be observed for erythema, edema, bruising, and bleeding at various timepoints throughout the study. 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.