RecruitingPhase 1

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

Belgium36 participantsStarted 2026-05-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: Pre-dose to 72 hours

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

Timeframe: Pre-dose to 72 hours

Trial details

NCT IDNCT07594769

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

Pfizer CT.gov Call Center

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

View on ClinicalTrials.gov More Migraine trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 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

Timeframe: Pre-dose to 72 hours

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

Timeframe: Pre-dose to 72 hours