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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014