Healthy Volunteer
Conditions
Keywords
Healthy volunteers
Brief summary
The purpose of this study is to assess the bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of different formulations of a CGRP receptor antagonist in healthy adult participants. 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.
Interventions
DRUGTest formulation (Treatment A)
calcitonin gene-related peptide receptor inhibitor
DRUGReference formulation (Treatment B)
calcitonin gene-related peptide receptor inhibitor
DRUGTest formulation (Treatment C)
calcitonin gene-related peptide receptor inhibitor
DRUGTest formulation (Treatment D)
calcitonin gene-related peptide receptor inhibitor
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion: 1. Male and/or female participants must be 18 years of age 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, and laboratory tests. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the Plasma Concentration-Time profile from time 0 extrapolated to infinite time (AUCinf) of the test and reference formulations | Pre-dose to 72 hours |
| Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (AUClast) of the test and reference formulations | Pre-dose to 72 hours |
| Maximum Observed Plasma Concentration (Cmax) of test and reference formulations | Predose to 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Baseline up to 36 days after the last dose of study intervention |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed