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Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Kalamazoo, Michigan, 49007 United States
Contact
1-800-718-1021
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" 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

NCT01199029
Pfizer
Completed
Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate

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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
Intervention Model: Crossover Assignment
Masking: None (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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01199029
B0861004
No
Not Provided
Not Provided
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

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