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

NCT07261371 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-05-04

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2026-04-22
Completion
2026-04-22
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 NCT07261371 on ClinicalTrials.gov