A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants
NCT05960032 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2025-01-06
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
- DRUG
-
Zavegepant
Participants receiving single dose of Zavegepant 10 mg
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-10-23
- Primary Completion
- 2023-12-12
- Completion
- 2023-12-12
- FDA Drug
- Yes
Countries
- China
Study Locations
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