A Study to Compare Blood Levels of Two Different Dosage Formulations of the Study Medicine Called CGRP Receptor Antagonist in Healthy Adults
NCT ID: NCT07261371
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2025-11-24
2026-05-08
Brief Summary
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The study is seeking participants who are:
1. Healthy males and females 18 years of age or older
2. Willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures.
3. Body Mass Index of 16-32 kilogram per meter squared (kg/m2); and a total body weight \>45 kg
The study will help the team understand how difference in formulation may, or may not, affect how the medicine is absorbed, processed, and removed by the body.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Treatment Sequence 1
Test formulation (Treatment A)
calcitonin gene-related peptide receptor inhibitor
Reference formulation (Treatment B)
calcitonin gene-related peptide receptor inhibitor
Treatment Sequence 2
Test formulation (Treatment A)
calcitonin gene-related peptide receptor inhibitor
Reference formulation (Treatment B)
calcitonin gene-related peptide receptor inhibitor
Interventions
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Test formulation (Treatment A)
calcitonin gene-related peptide receptor inhibitor
Reference formulation (Treatment B)
calcitonin gene-related peptide receptor inhibitor
Eligibility Criteria
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Inclusion Criteria
2. BMI of 16-32 kg/m2; and a total body weight \>45 kg.
3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion:
1. 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).
2. 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.
3. 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.
4. 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.
5. A positive urine drug test. A single repeat for positive drug screen may be allowed.
6. Unwilling or unable to comply with the Lifestyle Considerations criteria of this study
18 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4951081
Identifier Type: -
Identifier Source: org_study_id
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