Skip to main content
OpenTrials
Completed

NCT Number: NCT07261371

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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.
  • BMI of 16-32 kg/m2; and a total body weight >45 kg.
  • 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:

  • 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).
  • 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.
  • 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.
  • 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.
  • A positive urine drug test. A single repeat for positive drug screen may be allowed.
  • Unwilling or unable to comply with the Lifestyle Considerations criteria of this study

Treatment and study plan

Test formulation (Treatment A)

Drug

calcitonin gene-related peptide receptor inhibitor

Reference formulation (Treatment B)

Drug

calcitonin gene-related peptide receptor inhibitor

Test formulation (Treatment C)

Drug

calcitonin gene-related peptide receptor inhibitor

Test formulation (Treatment D)

Drug

calcitonin gene-related peptide receptor inhibitor

Primary outcomes

  1. Area under the Plasma Concentration-Time profile from time 0 extrapolated to infinite time (AUCinf) of the test and reference formulations

    Time frame: Pre-dose to 72 hours

  2. Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (AUClast) of the test and reference formulations

    Time frame: Pre-dose to 72 hours

  3. Maximum Observed Plasma Concentration (Cmax) of test and reference formulations

    Time frame: Predose to 72 hours

Secondary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Baseline up to 36 days after the last dose of study intervention

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.