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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Zavegepant

Registration Number: NCT05960032

Lead Sponsor: Pfizer

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 13

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zavegepant	Zavegepant	Participants receiving Zavegepant for the treatment phase of the study

Primary Outcome Measures

Name	Time	Method
Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	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	Maximum plasma concentration (Cmax) was measured.
AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	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, area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast), was measured.
AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	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, area under the plasma concentration-time curve from time 0 extrapolated to infinite time, was measured.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Day 1 up to maximum of 35 days post single dose administration	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.
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	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	Tmax, time to Cmax, was measured.
t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	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, terminal half-life, was measured.
CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	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, apparent clearance, was measured.
Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN	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, apparent volume of distribution, was measured.