Current partner codePEPTIDESDE
NCT07261371·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

64

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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

From registration to results.

  1. First posted

    Dec 3, 2025

  2. Study start

    Nov 24, 2025

  3. Primary completion

    Apr 22, 2026

  4. Study completion

    Apr 22, 2026

  5. Results posted

    Not reported

  6. Registry updated

    May 4, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

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

Time frame · Predose to 72 hours

Secondary outcomes

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
Yes

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Calcitonin.

Related PeptideStat pages

Put the record in context.

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