- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01522807
A Study Of Three PF-05190457 Formulations In Healthy Volunteers
January 27, 2012 updated by: Pfizer
A Phase I, Cross-Over, Single Dose, Double-Blind Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-05190457 In Healthy Adult Volunteers
The purpose of the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
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
-
-
-
Singapore, Singapore, 188770
- 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
21 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy males and females of non-childbearing potential between ages of 21 and 55 years, BMI of 17.5 to 30.5 kg/m^2, and weight above 50 kg.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 100 mg PF-05190457
Three fasted treatments and fed with the short-duration osmotic capsule
|
100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state
|
Experimental: 100 mg PF - 05190457
Three fasted treatments and fed with the long-duration osmotic capsule
|
100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between formulations as data permit.
Time Frame: 0 - 48 hours post dose
|
0 - 48 hours post dose
|
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between formulations as data permit.
Time Frame: 0 - 48 hours post dose
|
0 - 48 hours post dose
|
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Time of Maximum concentration (Tmax) as data permit.
Time Frame: 0 - 48 hours post dose
|
0 - 48 hours post dose
|
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Elimination of half-life (t ½ ) as data permit.
Time Frame: 0 - 48 hours post dose
|
0 - 48 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between fed states as data permit.
Time Frame: 0 - 48 hours post dose
|
0 - 48 hours post dose
|
The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between fed states as data permit.
Time Frame: 0 - 48 hours post dose
|
0 - 48 hours post dose
|
Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated.
Time Frame: 0 - 24 hours post dose
|
0 - 24 hours post dose
|
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
September 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
October 30, 2011
First Submitted That Met QC Criteria
January 27, 2012
First Posted (Estimate)
February 1, 2012
Study Record Updates
Last Update Posted (Estimate)
February 1, 2012
Last Update Submitted That Met QC Criteria
January 27, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B3301007
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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