Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate

Study Overview
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Brief Summary
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This study will investigate the effect of a single dose of PF-04308515 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test.

Official Title
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An Open Label Study Evaluating The Effect Of Single Doses Of Pf-04308515 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04308515
* Drug: PF-04308515
* Drug: Prednisone
* Drug: PF-04308515
* Drug: PF-04308515
* Drug: Prednisone
* Drug: Prednisone


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Part 1) 10 mg PF-04308515 (8hrs)<br> | Drug: PF-04308515<br>* 10 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test(OGTT)<br>|
| Experimental: (Part 1) 10 mg PF-04308515 (12hrs)<br> | Drug: PF-04308515<br>* 10 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test(OGTT)<br>|
| Active Comparator: (Part 1) 5 mg Prednisone<br> | Drug: Prednisone<br>* 5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)<br>|
| Experimental: (Part 2) X mg PF-04308515<br> | Drug: PF-04308515<br>* X mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT)<br>|
| Experimental: (Part 2) Y mg PF-04308515<br> | Drug: PF-04308515<br>* Y mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT)<br>|
| Active Comparator: (Part 2) 5 mg Prednisone<br> | Drug: Prednisone<br>* 5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)<br>|
| Active Comparator: (Part 2) 20 mg Prednisone<br> | Drug: Prednisone<br>* 20 mg (5 mg tablets) predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma C-peptide |  | 3 days | 
| Safety: adverse events, vital sign measurements, physical examination |  | 3 days | 
| Pharmacokinetics: sparse PF-04308515 plasma samples will be collected |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy People, Glucocorticoids, Prednisone