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

NCT05960032 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C5301009
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Zavegepant; Healthy volunteer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  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

  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

Study Arms (1)

Zavegepant

EXPERIMENTAL

Participants receiving Zavegepant for the treatment phase of the study

Drug: Zavegepant

Interventions

Zavegepant DRUG

Participants receiving single dose of Zavegepant 10 mg

Zavegepant

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, 201107, China

Location

Related Links

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: July 25, 2023
• Study Start: October 23, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)