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

NCT ID: NCT01199900

Last Updated: 2010-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy People Glucocorticoids Prednisone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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(Part 1) 25 mg PF-04171327 predosed at -8 hours prior to OGTT

Group Type EXPERIMENTAL

PF-04171327

Intervention Type DRUG

25 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test (OGTT)

(Part 1) 25 mg PF-04171327 predosed at -12 hours prior to OGTT

Group Type EXPERIMENTAL

PF-04171327

Intervention Type DRUG

25 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test (OGTT)

(Part 1) 5 mg Prednisone

5 mg prednisone tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)

(Part 2) 3 mg PF-04171327

Group Type EXPERIMENTAL

PF-04171327

Intervention Type DRUG

3 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)

(Part 2) 10 mg PF-04171327

Group Type EXPERIMENTAL

PF-04171327

Intervention Type DRUG

10 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)

(Part 2) 5 mg Prednisone

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)

(Part 2) 20 mg Prednisone

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

5 mg tablets predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)

Interventions

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PF-04171327

25 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test (OGTT)

Intervention Type DRUG

PF-04171327

25 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test (OGTT)

Intervention Type DRUG

Prednisone

5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)

Intervention Type DRUG

PF-04171327

3 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)

Intervention Type DRUG

PF-04171327

10 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)

Intervention Type DRUG

Prednisone

5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)

Intervention Type DRUG

Prednisone

5 mg tablets predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Kalamazoo, Michigan, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9391006&StudyName=Single%20Dose%20Study%20Of%20PF-04171327%20And%20Prednisone%20On%20Carbohydrate%20Metabolism

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

Other Identifiers

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A9391006

Identifier Type: -

Identifier Source: org_study_id