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CGRP Receptor Antagonist

Zavegepant for Healthy Breastfeeding Women

Phase 1
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be willing to temporarily discontinue breastfeeding their infants for a total of 2.5 days, regularly pump breasts, and discard breast milk expressed following zavegepant administration through 48 hours after the dose
Be between 18 and 65 years old
Must not have
Clinically significant abnormal laboratory test results or positive drug screen
History of gallstone or cholecystectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours
Awards & highlights

Summary

"This trial aims to study the levels of zavegepant in breast milk after administering a single dose through the nose to healthy breastfeeding women. The goal is to determine if there are any potential risks

Who is the study for?
This trial is for healthy breastfeeding women aged 18 to 55, who are at least two weeks post-partum and not currently pregnant. Participants must be willing to refrain from breastfeeding their infant from the day before receiving the study medication until 48 hours after dosing.
What is being tested?
The study tests how zavegepant, administered as a nasal spray in a single dose of 10mg, transfers into breast milk. Researchers will monitor levels in breast milk and blood over a period of 24 hours to assess any potential risks to infants during breastfeeding.
What are the potential side effects?
While specific side effects are not detailed here, participants may experience reactions typical of nasal sprays such as irritation or discomfort at the site of application. Any other side effects will be monitored during the stay in the clinical research unit.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to stop breastfeeding for 2.5 days after taking zavegepant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have abnormal lab results or a positive drug test.
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I have had gallstones or my gallbladder removed.
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I haven't taken OATP1B3 inhibitors in the last 14 days or 5 half-lives.
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I have a history of seizures, not just a fever-related one in childhood.
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I have signs of organ problems or unusual physical or nasal findings.
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I have no piercings or issues in my nose that could affect treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Breast Milk Concentration-time Profile From Time Zero to the Time of 24 hr post dose (AUC24)
Area Under the Breast Milk Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Area Under the Breast Milk Concentration-time Profile from time 0 extrapolated to infinite time (AUCinf), if data permit
Secondary study objectives
Area under the concentration-time profile from time 0 extrapolated to infinite time (AUCinf), if data permit
Area under the concentration-time profile from time 0 to 24 hours post dose (AUC24)
Area under the concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Zavegepant 10mgExperimental Treatment1 Intervention
Intranasal (IN) 10mg spray on Day 1

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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
4,625 Previous Clinical Trials
14,284,182 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,458,758 Total Patients Enrolled
~6 spots leftby Feb 2025
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