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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Part 1) 25 mg PF-04171327 predosed at -8 hours prior to OGTT | Experimental |
| |
| (Part 1) 25 mg PF-04171327 predosed at -12 hours prior to OGTT | Experimental |
| |
| (Part 1) 5 mg Prednisone | Active Comparator | 5 mg prednisone tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT) |
|
| (Part 2) 3 mg PF-04171327 | Experimental |
| |
| (Part 2) 10 mg PF-04171327 | Experimental |
| |
| (Part 2) 5 mg Prednisone | Active Comparator |
| |
| (Part 2) 20 mg Prednisone | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04171327 | Drug | 25 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test (OGTT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fold change in AUC (0-4h) relative to no treatment baseline for plasma glucose, plasma insulin, and plasma C-peptide | 4 hours |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Kalamazoo | Michigan | 49007 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C000615597 | fosdagrocorat |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| PF-04171327 | Drug | 25 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test (OGTT) |
|
| Prednisone | Drug | 5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT) |
|
| PF-04171327 | Drug | 3 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT) |
|
| PF-04171327 | Drug | 10 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT) |
|
| Prednisone | Drug | 5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT) |
|
| Prednisone | Drug | 5 mg tablets predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT) |
|
| Pharmacokinetics: sparse plasma samples will be collected for characterization of PF-0251802 pharmacokinetics (PK) |
| 3 days |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |