- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01563497
A Study Comparing PF-05089771 TS Tablet to PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And Fed State
March 23, 2012 updated by: Pfizer
A Phase 1, Open-Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Tablet To PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And The Fed State
The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 tablet.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bruxelles, Belgium, B-1070
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal,endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest 7. Single 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds >120 mseca the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PF-05089771 Oral Dispersion fasted
Oral dispersion TS formulation- fasted
|
Oral dispersion TS formulation- fasted
Tablets TS formulation- fasted
Tablets TS formulation- fed
|
Experimental: PF-05089771 TS formulation fasted
Tablets TS formulation- fasted
|
Oral dispersion TS formulation- fasted
Tablets TS formulation- fasted
Tablets TS formulation- fed
|
Experimental: PF-05089771 TS formulation fed
Tablets TS formulation- fed
|
Oral dispersion TS formulation- fasted
Tablets TS formulation- fasted
Tablets TS formulation- fed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)
Time Frame: days 1-3
|
days 1-3
|
AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL)
Time Frame: days 1-3
|
days 1-3
|
AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)
Time Frame: days 1-3
|
days 1-3
|
Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)
Time Frame: days 1-3
|
days 1-3
|
t½ = Elimination half life of PF-05089771 (hr)
Time Frame: days 1-3
|
days 1-3
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring.
Time Frame: days 1-3
|
days 1-3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
March 23, 2012
First Submitted That Met QC Criteria
March 23, 2012
First Posted (Estimate)
March 27, 2012
Study Record Updates
Last Update Posted (Estimate)
March 27, 2012
Last Update Submitted That Met QC Criteria
March 23, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- B3291007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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