A PHASE 1, OPEN LABEL, SINGLE DOSE, RANDOMIZED, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF DIFFERENT FORMULATIONS OF A CGRP RECEPTOR ANTAGONIST IN HEALTHY ADULT PARTICIPANTS
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Area under the Plasma Concentration-Time profile from time 0 extrapolated to infinite time (AUCinf) of the test and reference formulations
Study Overview
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:
- Healthy males and females 18 years of age or older
- Willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •BMI of 16-32 kg/m2; and a total body weight >45 kg.
- •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 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
Arms & Interventions
Treatment Sequence 2 (Part 1)
Intervention: Test formulation (Treatment A) (Drug)
Treatment Sequence 1 (Part 2)
Intervention: Test formulation (Treatment D) (Drug)
Treatment Sequence 2 (Part 2)
Intervention: Test formulation (Treatment C) (Drug)
Treatment Sequence 1 (Part 1)
Intervention: Test formulation (Treatment A) (Drug)
Treatment Sequence 1 (Part 1)
Intervention: Reference formulation (Treatment B) (Drug)
Treatment Sequence 2 (Part 1)
Intervention: Reference formulation (Treatment B) (Drug)
Treatment Sequence 1 (Part 2)
Intervention: Test formulation (Treatment C) (Drug)
Treatment Sequence 2 (Part 2)
Intervention: Test formulation (Treatment D) (Drug)
Outcomes
Primary Outcomes
Area under the Plasma Concentration-Time profile from time 0 extrapolated to infinite time (AUCinf) of the test and reference formulations
Time Frame: 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
Time Frame: Pre-dose to 72 hours
Maximum Observed Plasma Concentration (Cmax) of test and reference formulations
Time Frame: Predose to 72 hours
Secondary Outcomes
- Number of participants with Clinically Significant Abnormalities in Laboratory Parameters(Baseline up to 36 days after the last dose of study intervention)
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)(Baseline up to 36 days after the last dose of study intervention)