NCT06137703

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1, single centre, open-label, single dose, 4-period, crossover study designed to compare the pharmacokinetics (PK) of zavegepant from three Test products and a Reference product (treatment D). 52 male and female healthy volunteers will be randomly assigned to one of 4 treatment sequences: ACBD, CDAB, BADC, and DBCA. In each period, subjects will receive one of the following: Treatment A, B, C, or D on Day 1, followed by 24 hours of PK and safety assessments. On Day 2 subjects will be discharged from the clinical site and instructed to return after at least a 7 day washout time has passed for subsequent periods of treatment. The study will include a screening visit from Day -28 to Day -2. Eligible subjects will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 2. There will be a washout period of at least 7 days between doses. Study Exit procedures will be performed after the last assessment on the morning of Day 2 of Period 4. Study Exit procedures will be performed as soon as possible in case of Early Termination. The total duration of study participation for each subject from Screening through Study Exit is anticipated to be approximately 6.5 weeks.

Conditions

• Biological Availability

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-08-24
• Primary completion: 2022-12-07
• Completion: 2022-12-07
• First posted: 2023-11-18
• Last updated: 2024-10-01
• Results posted: 2024-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study