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
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
- lead INDUSTRY
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
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