OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS
A PHASE 1, OPEN LABEL, TWO-PERIOD, RANDOMIZED CROSSOVER STUDY TO COMPARE THE PHARMACOKINETICS OF TWO DIFFERENT FORMULATIONS OF PF-05221304 ADMINISTERED ORALLY TO HEALTHY ADULT SUBJECTS
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Mar 2019
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedStudy Start
First participant enrolled
March 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2019
CompletedMay 20, 2020
May 1, 2020
2 months
February 25, 2019
May 18, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Plasma PF-05221304 AUClast
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Thirteen timepoints between 0-72 Hours
Plasma PF-05221304 Cmax
Maximum Observed Plasma Concentration (Cmax)
Thirteen timepoints between 0-72 Hours
Secondary Outcomes (4)
Number of Subjects Experiencing an Adverse Event
Up to 10 weeks from screening
Number of Participants With Clinical Laboratory Abnormalities
Up to 10 weeks from screening
Number of Participants With Categorical Vital Signs Data
Up to 10 weeks from screening
Number of Participants With Abnormal Electrocardiogram (ECG)
Up to 10 weeks from screening
Study Arms (2)
PF-05221304 Formulation A
EXPERIMENTALPF-05221304 Formulation B
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Ages of 18 and 55 years old inclusive
- Body Mass Index (BMI) of \>= 17.5 and \<= 30.4 kg/m2
- Total body weight \> 50 kg (110lb)
You may not qualify if:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2019
First Posted
March 12, 2019
Study Start
March 13, 2019
Primary Completion
May 8, 2019
Study Completion
May 8, 2019
Last Updated
May 20, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.