A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy Adults

NCT07594769 | Not Yet Recruiting Phase 1

• 1 other identifier: C4951092
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the bioequivalence of an alternative ODT formulation (ODT2) versus the approved ODT formulation of a CGRP receptor antagonist in healthy adult participants under fasting conditions.

Conditions

Migraine

Outcome Measures

Primary Outcomes (3)

• Area under the plasma concentration-time curve from time zero extraploated to infinite time (AUCinf) of the test and reference formulations

  Pre-dose to 72 hours

• Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast) of the test and reference formulations

  Pre-dose to 72 hours

• Maximum observed plasma concentration (Cmax) of test and reference formulations

  Pre-dose to 72 hours

Secondary Outcomes (1)

• Number of participants with treatment emergent adverse events (TEAEs)

  From baseline up to 36 days after last dose of study intervention

Study Arms (2)

Treatment Sequence 1

EXPERIMENTAL

Drug: ODT2 Test formulation; Drug: ODT Reference formulation

Treatment Sequence 2

EXPERIMENTAL

Drug: ODT2 Test formulation; Drug: ODT Reference formulation

Interventions

ODT2 Test formulation DRUG

Test Formulation

Treatment Sequence 1; Treatment Sequence 2

ODT Reference formulation DRUG

Reference Formulation

Treatment Sequence 1; Treatment Sequence 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 18 years 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, laboratory tests, and ECGs.
• Have a body mass index (BMI) of 16-32 kg/m2, and a body weight \>45 kg.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

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

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): September 7, 2026
• Study Completion (Estimated): September 7, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)