A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants

A PHASE 1, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF ZAVEGEPANT INTRANASAL ADMINISTRATION IN HEALTHY CHINESE ADULT PARTICIPANTS

The purpose of this study is to learn about:

• how Zavegepant is changed and removed from the body after taken.
• safety of Zavegepant.
• the extent to which side effects can be tolerated after taking Zavegepant for the possible short-term treatment of migraine.

This study is seeking participants who:

• are healthy Chinese adults and includes participants who are between 18 to 55 years old.
• have body mass index (BMI) of 18 to 30 kg/m^2.
• have a total body weight of:
• equal to or more than 50 kilograms (110 pounds) for males.
• equal to or more than 45 kilograms (99 pounds) for females.
• are non-smoker (no use of tobacco or nicotine products).

All participants in this study will receive Zavegepant by nose, once at the study clinic.

The experiences of the participants receiving the study medicine will be looked at. This will help see if the study medicine is safe.

Participants will take part in this study for around 9 weeks. During this time, participants will have 2 study visits at the study clinic and 1 contact over the phone.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Zavegepant

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201107
      • Huashan Hospital,Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy Chinese adults and includes participants who are between 18 to 55 years old
• BMI of 18 to 30 kg/m^2; and a total body weight ≥50 kg (110 lb) for males and ≥45 kg (99 lb) for females
• Non-smoker (no use of tobacco or nicotine products).

Exclusion Criteria:

• Evidence or history of clinically significant disease.
• Use of medication other than topical products without significant systemic absorption.
• Previous participantion in a clinical research study or investigational study prior to the first dosing.
• Any clinically significant abnormal laboratory test results or positive test.
• Evidence of organ dysfunction or any clinically significant deviation from normal.
• Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic).
• Standard 12-lead ECG that demonstrates clinically relevant abnormalities.
• Abnormalities in clinical laboratory tests: AST or ALT level > ULN; Total bilirubin level > ULN; ANC or ALC level > ULN.
• Positive urine drug screen, alcohol breath test, or urine cotinine test.
• Positive pregnancy test.
• Positive result for COVID-19.
• History of significant alcohol abuse or drug abuse.
• History of anaphylaxix reaction or a clinically important reaction to any drug.
• Donation of plasma within 30 days prior to dosing. Donation or loss of blood of approximately 400 mL or more within 60 days prior to dosing.
• Inability to be venipunctured and/or tolerate catheter venous access.
• Habitual use of snuff tobacco.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zavegepant; Participants receiving Zavegepant for the treatment phase of the study	Drug: Zavegepant; Participants receiving single dose of Zavegepant 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	Maximum plasma concentration (Cmax) was measured.	0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1
AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	AUClast, area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast), was measured.	0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1
AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	AUCinf, area under the plasma concentration-time curve from time 0 extrapolated to infinite time, was measured.	0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, including untoward findings on physical examinations captured as AEs if any.	Day 1 up to maximum of 35 days post single dose administration
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)		Day 1 up to maximum of 35 days post single dose administration
Number of Participants With Clinically Significant Values of Vital Signs		Day 1 up to maximum of 35 days post single dose administration
Number of Participants With Clinically Significant Values of 12-lead ECGs		Day 1 up to maximum of 35 days post single dose administration
Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	Tmax, time to Cmax, was measured.	0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1
t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	T1/2, terminal half-life, was measured.	0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1
CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	CL/F, apparent clearance, was measured.	0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1
Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	Vz/F, apparent volume of distribution, was measured.	0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: July 16, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Healthy volunteer; Zavegepant
• Other Study ID Numbers: C5301009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes