CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
Zavegepantdrug
Likely dose
Zavegepant 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05960032
NCT05960032Phase 1Completed

A PHASE 1, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF ZAVEGEPANT INTRANASAL ADMINISTRATION IN HEALTHY CHINESE ADULT PARTICIPANTS

Pfizer·interventional·Posted Jul 25, 2023·Updated Jan 6, 2025

In Brief

A Phase 1 clinical trial evaluating Zavegepant for Healthy. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedJul 25, 2023
Enrollment StartOct 23, 2023
Primary CompletionDec 12, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 2.9 years ago

Interventions

Zavegepantdrug

Participants receiving single dose of Zavegepant 10 mg