NCT05960032

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Zavegepant	Participants receiving single dose of Zavegepant 10 mg

Timeline

• Start date: 2023-10-23
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2023-07-25
• Last updated: 2025-01-06
• Results posted: 2025-01-06

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study