NCT07261371

A Study to Compare Blood Levels of Different Dosage Formulations of the Study Medicine That Is a CGRP Receptor Antagonist in Healthy Adults

A PHASE 1, OPEN LABEL, SINGLE DOSE, RANDOMIZED, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF DIFFERENT FORMULATIONS OF A CGRP RECEPTOR ANTAGONIST IN HEALTHY ADULT PARTICIPANTS

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of different formulations of a CGRP receptor antagonist in healthy adult participants. The study is seeking participants who are: 1. Healthy males and females 18 years of age or older 2. Willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures. 3. Body Mass Index of 16-32 kilogram per meter squared (kg/m2); and a total body weight \>45 kg The study will help the team understand how difference in formulation may, or may not, affect how the medicine is absorbed, processed, and removed by the body.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Test formulation (Treatment A)	calcitonin gene-related peptide receptor inhibitor
DRUG	Reference formulation (Treatment B)	calcitonin gene-related peptide receptor inhibitor
DRUG	Test formulation (Treatment C)	calcitonin gene-related peptide receptor inhibitor
DRUG	Test formulation (Treatment D)	calcitonin gene-related peptide receptor inhibitor

Timeline

• Start date: 2025-11-24
• Primary completion: 2026-05-13
• Completion: 2026-05-13
• First posted: 2025-12-03
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study