Back to resultsA Study Of Three PF-05190457 Formulations In Healthy Volunteers
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
PF-05190457
PF-05190457
PF-05190457
PF-05190457
PF-05190457
PF-05190457
PF-05190457
PF-05190457
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Phase 1, Single Doses, Biocomparison, Pharmacokinetics, Healthy Volunteers
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
100 mg PF-05190457
100 mg PF - 05190457
Arm Description
Three fasted treatments and fed with the short-duration osmotic capsule
Three fasted treatments and fed with the long-duration osmotic capsule
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01522807
Brief Title
A Study Of Three PF-05190457 Formulations In Healthy Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Phase 1, Single Doses, Biocomparison, Pharmacokinetics, Healthy Volunteers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100 mg PF-05190457
Arm Type
Experimental
Arm Description
Three fasted treatments and fed with the short-duration osmotic capsule
Arm Title
100 mg PF - 05190457
Arm Type
Experimental
Arm Description
Three fasted treatments and fed with the long-duration osmotic capsule
Intervention Type
Drug
Intervention Name(s)
PF-05190457
Intervention Description
100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
Intervention Type
Drug
Intervention Name(s)
PF-05190457
Intervention Description
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
Intervention Type
Drug
Intervention Name(s)
PF-05190457
Intervention Description
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
Intervention Type
Drug
Intervention Name(s)
PF-05190457
Intervention Description
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state
Intervention Type
Drug
Intervention Name(s)
PF-05190457
Intervention Description
100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
Intervention Type
Drug
Intervention Name(s)
PF-05190457
Intervention Description
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
Intervention Type
Drug
Intervention Name(s)
PF-05190457
Intervention Description
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
Intervention Type
Drug
Intervention Name(s)
PF-05190457
Intervention Description
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3301007&StudyName=A%20Study%20Of%20Three%20PF-05190457%20Formulations%20In%20Healthy%20Volunteers
Description
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Learn more about this trial
A Study Of Three PF-05190457 Formulations In Healthy Volunteers
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