NCT04969497

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Zosano Pharma Corporation · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Treatment A: M207 3.8 mg "MiniMac"	Treatment A: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a "MiniMac" coater and packaged in foil cups
DRUG	Treatment B: M207 3.8 mg "MACAP"	Treatment B: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a "MACAP" coater and packaged in foil cups
DRUG	Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0	Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0

Timeline

• Start date: 2021-06-24
• Primary completion: 2021-09-02
• Completion: 2021-09-02
• First posted: 2021-07-20
• Last updated: 2021-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study