A Study to Compare the Blood Levels of Two Dosage Formula... | NCT07594769

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

NCT07594769

Sponsor

Pfizer

Status

Recruiting

Last Update Posted

Jun 10, 2026Actual

Enrollment

36Estimated

Phase

Phase 1

Conditions

Migraine

Interventions

ODT2 Test formulation
ODT Reference formulation

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 8, 2026Actual

Primary Completion Date

Aug 31, 2026Estimated

Completion Date

Aug 31, 2026Estimated

First Submitted Date

May 12, 2026

First Submission Date that Met QC Criteria

May 12, 2026

First Posted Date

May 19, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2026

Last Update Posted Date

Jun 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

To evaluate the bioequivalence of ODT2 (Test) versus approved ODT (Reference) formulations administered on top of the tongue in healthy adult participants under fasting conditions.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ODT2 Test formulation	Drug	Test Formulation	Treatment Sequence 1 Treatment Sequence 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the plasma concentration-time curve from time zero extrapolated 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

Measure	Description	Time Frame
Number of participants with treatment emergent adverse events (TEAEs)		From baseline up to 36 days after last dose of study intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Pfizer CT.gov Call Center	Contact	1-800-718-1021		ClinicalTrials.gov_Inquiries@pfizer.com

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Clinical Research Unit - Brussels	Recruiting	Brussels	Bruxelles-capitale, Région de	B-1070	Belgium

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases