Healthy
Conditions
Keywords
Healthy People, Glucocorticoids, Prednisone
Brief summary
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.
Interventions
DRUGPF-04308515
10 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test(OGTT)
DRUGPrednisone
5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed