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

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NCT01199900

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Study Location
Pfizer Investigational Site
Kalamazoo, Michigan, 49007, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
Brief Title  ICMJE Single Dose Study Of PF-04171327 And Prednisone On Carbohydrate Metabolism
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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: Prednisone
    5 mg tablet predosed at 8 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)
  • Drug: Prednisone
    5 mg tablets predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Study Arms  ICMJE
  • Experimental: (Part 1) 25 mg PF-04171327 predosed at -8 hours prior to OGTT
    Intervention: Drug: PF-04171327
  • Experimental: (Part 1) 25 mg PF-04171327 predosed at -12 hours prior to OGTT
    Intervention: Drug: PF-04171327
  • Active Comparator: (Part 1) 5 mg Prednisone
    5 mg prednisone tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
    Intervention: Drug: Prednisone
  • Experimental: (Part 2) 3 mg PF-04171327
    Intervention: Drug: PF-04171327
  • Experimental: (Part 2) 10 mg PF-04171327
    Intervention: Drug: PF-04171327
  • Active Comparator: (Part 2) 5 mg Prednisone
    Intervention: Drug: Prednisone
  • Active Comparator: (Part 2) 20 mg Prednisone
    Intervention: Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2010)		18
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2010)		34
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01199900
Other Study ID Numbers  ICMJE A9391006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP