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Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01199029
First received: September 9, 2010
Last updated: December 15, 2010
Last verified: December 2010

September 9, 2010
December 15, 2010
August 2010
September 2010   (final data collection date for primary outcome measure)
Fold change in AUC (0-4hr) relative to no treatment baseline for plasma glucose, plasma insulin and plasma C-peptide [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01199029 on ClinicalTrials.gov Archive Site
  • Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma C-peptide [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Safety: adverse events, vital sign measurements, physical examination [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: sparse PF-04308515 plasma samples will be collected [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: PF-04308515
    10 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test(OGTT)
  • Drug: PF-04308515
    10 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-04308515
    X mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
  • Drug: PF-04308515
    Y mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
  • Drug: Prednisone
    20 mg (5 mg tablets) predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
  • Experimental: (Part 1) 10 mg PF-04308515 (8hrs)
    Intervention: Drug: PF-04308515
  • Experimental: (Part 1) 10 mg PF-04308515 (12hrs)
    Intervention: Drug: PF-04308515
  • Active Comparator: (Part 1) 5 mg Prednisone
    Intervention: Drug: Prednisone
  • Experimental: (Part 2) X mg PF-04308515
    Intervention: Drug: PF-04308515
  • Experimental: (Part 2) Y mg PF-04308515
    Intervention: Drug: PF-04308515
  • Active Comparator: (Part 2) 5 mg Prednisone
    Intervention: Drug: Prednisone
  • Active Comparator: (Part 2) 20 mg Prednisone
    Intervention: Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01199029
B0861004
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2010

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