A Study Of Three PF-05190457 Formulations In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01522807
First received: October 30, 2011
Last updated: January 27, 2012
Last verified: January 2012

October 30, 2011
January 27, 2012
September 2011
November 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01522807 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Of Three PF-05190457 Formulations In Healthy Volunteers
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Diabetes Mellitus, Type 2
  • Drug: PF-05190457
    100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
  • Drug: PF-05190457
    100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
  • Drug: PF-05190457
    100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
  • Drug: PF-05190457
    100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state
  • Drug: PF-05190457
    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 short-duration osmotic capsule
    Interventions:
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
  • Experimental: 100 mg PF - 05190457
    Three fasted treatments and fed with the long-duration osmotic capsule
    Interventions:
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
    • Drug: PF-05190457
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01522807
B3301007
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP