NCT03708744

A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers

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

• 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. 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.

Detailed description

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	A: M207 3.8mg, 30 min, upper arm	A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
DRUG	B: M207 3.8 mg, 30 min, thigh	B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
DRUG	C: M207 3.8 mg, 1 hr, upper arm	C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
DRUG	D:zolmitriptan nasal spray	D: 2.5 mg/0.1 mL intranasal zolmitriptan

Timeline

• Start date: 2018-11-01
• Primary completion: 2018-11-20
• Completion: 2018-11-20
• First posted: 2018-10-17
• Last updated: 2020-01-18
• Results posted: 2019-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study