A Study Of Three PF-05190457 Formulations In Healthy Volunteers

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01522807

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: PF-05190457 Drug: PF-05190457 Drug: PF-05190457 Drug: PF-05190457 Drug: PF-05190457 Drug: PF-05190457 Drug: PF-05190457 Drug: PF-05190457	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, 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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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. [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. [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. [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. [0 - 48 hours post dose]

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. [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. [0 - 48 hours post dose]
Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated. [0 - 24 hours post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.