NCT03978403

A Four-way Crossover Study of 3 Formulations of M207 With Intranasal Zolmitriptan in Healthy Volunteers

A Randomized Open-label Four-way Crossover Study of Pharmacokinetics, Safety, and Tolerability of 3 Formulations of M207 3.8 mg on the Upper Arm for 30 Minutes With Intranasal Zolmitriptan 2.5 mg in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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, four-way crossover study. Subjects will receive the four study treatments once, followed by in-clinic monitoring and extensive pharmacokinetic analysis. Dosing occurs \~48 hours apart from patch application, in randomized order. Subjects will have final assessment and be dismissed from the study.

Detailed description

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 from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. 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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches)	M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "Sled" coater and packaged in foil pouches
DRUG	M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups)	M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "MACAP" coater and packaged in foil cups
DRUG	M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups	M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "miniMac" coater and packaged in foil pouches
DRUG	Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose	Zolmitriptan 2.5 mg/0.1 mL nasal spray \[ZOMIG\] single dose

Timeline

• Start date: 2019-05-29
• Primary completion: 2019-06-28
• Completion: 2019-06-28
• First posted: 2019-06-07
• Last updated: 2021-11-18
• Results posted: 2021-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study