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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Test formulation (Treatment A); Drug: Reference formulation (Treatment B); Drug: Test formulation (Treatment C); Drug: Test formulation (Treatment D)

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Clinical Research Unit - New Haven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion:

1. Male and/or female participants must be 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
2. BMI of 16-32 kg/m2; and a total body weight >45 kg.
3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
2. Any medical, psychiatric condition, suicidal ideation and behavior, laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
3. Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
4. Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
5. A positive urine drug test. A single repeat for positive drug screen may be allowed.
6. Unwilling or unable to comply with the Lifestyle Considerations criteria of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Sequence 1 (Part 1)	Drug: Test formulation (Treatment A); calcitonin gene-related peptide receptor inhibitor; Drug: Reference formulation (Treatment B); calcitonin gene-related peptide receptor inhibitor
Experimental: Treatment Sequence 2 (Part 1)	Drug: Test formulation (Treatment A); calcitonin gene-related peptide receptor inhibitor; Drug: Reference formulation (Treatment B); calcitonin gene-related peptide receptor inhibitor
Experimental: Treatment Sequence 1 (Part 2)	Drug: Test formulation (Treatment C); calcitonin gene-related peptide receptor inhibitor; Drug: Test formulation (Treatment D); calcitonin gene-related peptide receptor inhibitor
Experimental: Treatment Sequence 2 (Part 2)	Drug: Test formulation (Treatment C); calcitonin gene-related peptide receptor inhibitor; Drug: Test formulation (Treatment D); calcitonin gene-related peptide receptor inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the Plasma Concentration-Time profile from time 0 extrapolated to infinite time (AUCinf) of the test and reference formulations	Pre-dose to 72 hours
Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (AUClast) of the test and reference formulations	Pre-dose to 72 hours
Maximum Observed Plasma Concentration (Cmax) of test and reference formulations	Predose to 72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs)	Baseline up to 36 days after the last dose of study intervention

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Actual): April 22, 2026
• Study Completion (Actual): April 22, 2026

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Healthy volunteers
• Other Study ID Numbers: C4951081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No