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

Pfizer13 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN

Maximum plasma concentration (Cmax) was measured.

Time frame: 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.

Time frame: 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.

Time frame: 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 Outcomes

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.

Time frame: Day 1 up to maximum of 35 days post single dose administration

Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

Time frame: Day 1 up to maximum of 35 days post single dose administration

Number of Participants With Clinically Significant Values of Vital Signs

Time frame: Day 1 up to maximum of 35 days post single dose administration

Number of Participants With Clinically Significant Values of 12-lead ECGs

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes