MedTrace Logo

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

NCT04969497 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-09-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Zosano Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Don Kellerman, PharmD · Zosano Pharma Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-24
Primary Completion
2021-09-02
Completion
2021-09-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04969497 on ClinicalTrials.gov