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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: PF-05190457
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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. [ 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 ]

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. [ 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 ]

Enrollment: 16
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100 mg PF-05190457
Three fasted treatments and fed with the short-duration osmotic capsule
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
Experimental: 100 mg PF - 05190457
Three fasted treatments and fed with the long-duration osmotic capsule
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 long-duration osmotic capsule in the fed state

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522807

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01522807     History of Changes
Other Study ID Numbers: B3301007
Study First Received: October 30, 2011
Last Updated: January 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
Single Doses
Biocomparison
Pharmacokinetics
Healthy Volunteers

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014