Clinical trial NCT05960032: A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants
Official title: A PHASE 1, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF ZAVEGEPANT INTRANASAL ADMINISTRATION IN HEALTHY CHINESE ADULT PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Zavegepant
Healthy volunteer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-07-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
timeFrame: 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
measure: AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
timeFrame: 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
measure: AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
timeFrame: 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:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to maximum of 35 days post single dose administration
measure: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: Day 1 up to maximum of 35 days post single dose administration
measure: Number of Participants With Clinically Significant Values of Vital Signs
timeFrame: Day 1 up to maximum of 35 days post single dose administration
measure: Number of Participants With Clinically Significant Values of 12-lead ECGs
timeFrame: Day 1 up to maximum of 35 days post single dose administration
measure: Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
timeFrame: 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
measure: t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
timeFrame: 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
measure: CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
timeFrame: 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
measure: Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
timeFrame: 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
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital,Fudan University
state: Shanghai
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: