CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 enrolled
Drug / intervention
Zavegepant 100mg non-enteric coated soft gel capsule +3 moredrug
Likely dose
Zavegepant 100mg non-enteric coated soft gel capsulefrom 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/NCT06137703
NCT06137703Phase 1Completed
CompareCT.gov

A PHASE 1, OPEN-LABEL, RANDOMIZED, 4-PERIOD, 4-WAY CROSSOVER, RELATIVE BIOAVAILABILITY STUDY OF ZAVEGEPANT (BHV-3500) ORAL FORMULATIONS UNDER FASTING CONDITIONS

Pfizer·interventional·Posted Nov 18, 2023·Updated Oct 1, 2024

In Brief

A Phase 1 clinical trial evaluating Zavegepant 100mg non-enteric coated soft gel capsule, Zavegepant 100mg immediate release tablet, and 2 other interventions for Biological Availability. Completed, enrolled 52 participants across 1 site.

Detailed Summary

This trial is designed to compare the rate and extent of absorption of four different formulations of zavegepant. 52 healthy male and female volunteers will receive a single dose of each formulation at least 7 days apart over a period of about 7 weeks and the amount of drug in their blood will be assessed over the 24 hour period after each dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiological Availability
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedNov 18, 2023
Enrollment StartAug 24, 2022
Primary CompletionDec 7, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.6 years ago

Interventions

Zavegepant 100mg non-enteric coated soft gel capsuledrug

Zavegepant (PF-07930207/BHV3500) 100mg non-enteric coated soft gel capsule

Zavegepant 100mg immediate release tabletdrug

Zavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablet

Zavegepant 2 x 100mg immediate release tabletsdrug

2 x Zavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablets - total dose 200mg

Zavegepant 4 x 25mg enteric coated soft gel capsuledrug

Zavegepant (PF-07930207/BHV3500) 25 mg enteric coated soft gel capsules - total dose 100mg