A Study Of Three PF-05190457 Formulations In Healthy Volunteers

NCT01522807 | Completed Phase 1

• 1 other identifier: B3301007
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Phase 1; Single Doses; Biocomparison; Pharmacokinetics; Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (2)

100 mg PF-05190457

EXPERIMENTAL

Three fasted treatments and fed with the short-duration osmotic capsule

Drug: PF-05190457

100 mg PF - 05190457

EXPERIMENTAL

Three fasted treatments and fed with the long-duration osmotic capsule

Drug: PF-05190457

Interventions

PF-05190457 DRUG

100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state

100 mg PF-05190457

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

PF-5190457

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2011
• First Posted: February 1, 2012
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

SG (1)