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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-04171327; Drug: Prednisone

• Registration Number: NCT01199900
• Lead Sponsor: Pfizer

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-16
• Last Update Posted: 2010-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
(Part 1) 25 mg PF-04171327 predosed at -8 hours prior to OGTT	PF-04171327	-
(Part 1) 25 mg PF-04171327 predosed at -12 hours prior to OGTT	PF-04171327	-
(Part 1) 5 mg Prednisone	Prednisone	5 mg prednisone tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
(Part 2) 3 mg PF-04171327	PF-04171327	-
(Part 2) 10 mg PF-04171327	PF-04171327	-
(Part 2) 5 mg Prednisone	Prednisone	-
(Part 2) 20 mg Prednisone	Prednisone	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 plasma samples will be collected for characterization of PF-0251802 pharmacokinetics (PK)	3 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Kalamazoo, Michigan, United States