A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers
A Two Period, 2 Sequence Crossover To Establish The Relative Bioavailability Of A Single Pf-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers
1 other identifier
interventional
13
1 country
1
Brief Summary
This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when respectively given orally as a single tablet dose and a single dose of a solution.
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 Oct 2010
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
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 20, 2010
CompletedFirst Posted
Study publicly available on registry
November 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 2, 2011
January 1, 2011
2 months
October 20, 2010
January 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
adverse events
4 days
Plasma Pharmacokinetics for both tablet and solution dosage forms.
4 days
The relative bioavailability (Frel) of PF-04634817 when administered as a tablet compared with a solution.
4 days
lab measurements
4 days
vitals/ECG parameters
4 days
Study Arms (2)
single dose PF-04634817 tablet
ACTIVE COMPARATORsubjects receive a single dose of PF-04634817 as a tablet
single dose PF-04634817 solution
ACTIVE COMPARATORsubjects receive a single dose of PF-04634817 as a solution
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history and full physical examination.)
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
You may not qualify if:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
- Nursing females;
- Females of childbearing potential.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Incyte Corporationcollaborator
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Interventions
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
Study Record Dates
First Submitted
October 20, 2010
First Posted
November 24, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 2, 2011
Record last verified: 2011-01