Study of PK, Safety, and Tolerability of 2 Lots of M207 & Intranasal Zolmitriptan in Healthy Volunteers

Migraine Clinical Trial

Official title: A Randomized Open-Label Three-Way Crossover Study to Compare the Pharmacokinetics, Safety, and Tolerability of Two Lots of M207 3.8 mg (Administered as Two 1.9 mg Patches on the Upper Arm for 30 Minutes) and Intranasal Zolmitriptan 5.0 mg x 2 Doses in Healthy Volunteers

Status Completed

Clinical Trial Summary

This is a single-center, open-label, randomized, 3-way crossover study. Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for plasma PK analysis.

Dosing will occur at least 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. After completion dosing, subjects will be assessed one final time.

Clinical Trial Description

This is a single-center, open-label, randomized, three-way crossover study. Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis.

Dosing will occur at least 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. Subjects may be dosed in 2 or more separate groups in each period, for example, 24 subjects on one day and 24 subjects on another day.

Plasma samples from the dosing days will be sent to the analytical laboratory for analysis. Tolerability scores for each of the dose levels will be summarized.

After completion of the three dosing days, subjects will be assessed one final time and dismissed from the study. ;

Related Conditions & MeSH terms

• Migraine

• NCT number: NCT04969497
• Study type: Interventional
• Source: Zosano Pharma Corporation
• Status: Completed
• Phase: Phase 1
• Start date: June 24, 2021
• Completion date: September 2, 2021