MigrainePhase 1NCT07594769
A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy Adults
A Phase 1 study testing ODT2 Test formulation and ODT Reference formulation in people with Migraine, run by Pfizer at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- ODT2 Test formulation and ODT Reference formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- 11 May 2026to 1 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: A PHASE 1, OPEN LABEL, SINGLE DOSE, RANDOMIZED, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF TWO FORMULATIONS OF A CGRP RECEPTOR ANTAGONIST IN HEALTHY ADULT PARTICIPANTS
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- ODT2 Test formulation, ODT Reference formulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODT2 Test formulationDrug
Test Formulation
ODT Reference formulationDrug
Reference Formulation
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | Not described Receives: Drug: ODT2 Test formulation; Drug: ODT Reference formulation |
| Treatment Sequence 2 | Experimental | Not described Receives: Drug: ODT2 Test formulation; Drug: ODT Reference formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of the test and reference formulations
Measured: 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
Measured: Pre-dose to 72 hours
Maximum observed plasma concentration (Cmax) of test and reference formulations
Measured: Pre-dose to 72 hours
Secondary outcomes (1)
Number of participants with treatment emergent adverse events (TEAEs)
Measured: From baseline up to 36 days after last dose of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start11 May 2026
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594769
- Sponsor's protocol ID
- C4951092
- Status last verified
- Sep 2026
- First submitted
- 12 May 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN LABEL, SINGLE DOSE, RANDOMIZED, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF TWO FORMULATIONS OF A CGRP RECEPTOR ANTAGONIST IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT07594769
- Acronym / sponsor ID
- C4951092
- Conditions
- Migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: ODT2 Test formulation, Drug: ODT Reference formulation |
| Treatment Sequence 2 | Experimental | Drug: ODT2 Test formulation, Drug: ODT Reference formulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODT2 Test formulationTest Formulation | Drug | Treatment Sequence 1, Treatment Sequence 2 |
| ODT Reference formulationReference Formulation | Drug | Treatment Sequence 1, Treatment Sequence 2 |
Primary outcome
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of the test and reference formulations
Time frame: 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
Time frame: Pre-dose to 72 hours
Maximum observed plasma concentration (Cmax) of test and reference formulations
Time frame: Pre-dose to 72 hours
1 secondary outcome
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: From baseline up to 36 days after last dose of study intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ODT2 Test formulation and ODT Reference formulation in people with Migraine, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of the test and reference formulations (time frame: Pre-dose to 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.