Single Dose Study Of PF-04171327 And Prednisone On Carbohydrate Metabolism

December 16, 2010 updated by: Pfizer

An Open Label Study Evaluating The Effect Of Single Doses Of PF-04171327 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects

This study will investigate the effect of a single dose of PF-04171327 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI 17.5 to 30.5 kg/m2 and total body weight >50 kg

Exclusion Criteria:

  • Fasting glucose above the limits of the reference range for healthy individuals
  • "No treatment" Oral Glucose Tolerance Test (OGTT) indicative of impaired fasting glucose or impaired glucose tolerance
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: (Part 2) 5 mg Prednisone
Drug: Prednisone
5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: Prednisone
5 mg tablets predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Active Comparator: (Part 2) 20 mg Prednisone
Drug: Prednisone
5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: Prednisone
5 mg tablets predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Experimental: (Part 1) 25 mg PF-04171327 predosed at -8 hours prior to OGTT
Drug: PF-04171327
25 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
25 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
3 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
10 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
Experimental: (Part 1) 25 mg PF-04171327 predosed at -12 hours prior to OGTT
Drug: PF-04171327
25 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
25 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
3 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
10 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
Active Comparator: (Part 1) 5 mg Prednisone
5 mg prednisone tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: Prednisone
5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: Prednisone
5 mg tablets predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Experimental: (Part 2) 3 mg PF-04171327
Drug: PF-04171327
25 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
25 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
3 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
10 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
Experimental: (Part 2) 10 mg PF-04171327
Drug: PF-04171327
25 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
25 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
3 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
Drug: PF-04171327
10 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fold change in AUC (0-4h) relative to no treatment baseline for plasma glucose, plasma insulin, and plasma C-peptide
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: adverse events, vital sign measurements, physical examination
Time Frame: 3 days
3 days
Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma c-peptide
Time Frame: 3 days
3 days
Pharmacokinetics: sparse plasma samples will be collected for characterization of PF-0251802 pharmacokinetics (PK)
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

December 17, 2010

Last Update Submitted That Met QC Criteria

December 16, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9391006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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