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Recruiting NCT07594769

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

Phase I Interventional Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ODT2 Test formulation, ODT Reference formulation.
Who it may be relevant to
Registry conditions: Migraine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug ODT2 Test formulation
    Test Formulation
  • Drug ODT Reference formulation
    Reference Formulation

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Number of participants with treatment emergent adverse events (TEAEs) [Time frame: From baseline up to 36 days after last dose of study intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Belgium · 1 center
  • Pfizer Clinical Research Unit - Brussels — Brussels

Identifiers

NCT: NCT07594769 · C4951092

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗