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A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers

NCT03708744 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-01-18

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Zosano Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Don Kellerman, Pharm.D. · 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
2018-11-01
Primary Completion
2018-11-20
Completion
2018-11-20
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 NCT03708744 on ClinicalTrials.gov