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A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers

NCT06137703 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-10-01

Study results available
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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.

Conditions

  • Biological Availability

Interventions

DRUG

Zavegepant 100mg non-enteric coated soft gel capsule

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

DRUG

Zavegepant 100mg immediate release tablet

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

DRUG

Zavegepant 2 x 100mg immediate release tablets

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

DRUG

Zavegepant 4 x 25mg enteric coated soft gel capsule

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2022-12-07
Completion
2022-12-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06137703 on ClinicalTrials.gov