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Zavegepant 10 mg Intranasal (IN) for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 15, 30 minutes, 1, 1.5-, 2-, 3-, 4-, 6-, 8-, 12-, and 24-hour post-dose

Awards & highlights

Study Summary

This trial will study the effects of a drug called zavegepant using two different patient-centric devices for collecting liquid and dried blood samples. Taste assessments will also be done before and after administration. 14 people will participate for 9 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 15, 30 minutes, 1, 1.5-, 2-, 3-, 4-, 6-, 8-, 12-, and 24-hour post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 15, 30 minutes, 1, 1.5-, 2-, 3-, 4-, 6-, 8-, 12-, and 24-hour post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 15, 30 minutes, 1, 1.5-, 2-, 3-, 4-, 6-, 8-, 12-, and 24-hour post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apparent Oral Clearance (CL/F)

Apparent Volume of Distribution (Vz/F)

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) if data permits

+5 more

Secondary outcome measures

Assessment of Treatment Emergent Adverse Events (TEAE's)

Number of Participants With Clinical Laboratory Abnormalities

Trial Design

1Treatment groups

Experimental Treatment

Group I: Zavegepant 10 mg Intranasal (IN)Experimental Treatment1 Intervention

All participants will receive zavegepant 10 mg IN spray in period 1 and a butterscotch candy + zavegepant 10 mg IN spray in period 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zavegepant 10 mg IN

2023

Completed Phase 1

~20

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,859 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,093,027 Total Patients Enrolled

Media Library

Tasso-M20 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05948085 — Phase 1

Healthy Subjects Research Study Groups: Zavegepant 10 mg Intranasal (IN)

Healthy Subjects Clinical Trial 2023: Tasso-M20 Highlights & Side Effects. Trial Name: NCT05948085 — Phase 1

Tasso-M20 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05948085 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it safe to administer 10 mg Zavegepant Intranasally (IN) to patients?

"As this is an early-phase investigation, there are minimal data confirming the safety and effectiveness of Zavegepant 10 mg Intranasal (IN), resulting in a score of 1."

Answered by AI

Is the research team currently looking for participants in this experiment?

"According to clinicaltrials.gov, the current study is not actively recruiting participants - although it was originally posted on July 10th 2023 and most recently updated on 7/7/2023. However, there are currently 793 other trials that are now enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Compare Zavegepant Concentration Using Samples Collected From the Vein Versus Patient-Centric Microsampling

2023. "A Study to Compare Zavegepant Concentration Using Samples Collected From the Vein Versus Patient-Centric Microsampling". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05948085.