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The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04173127 | Experimental |
| |
| Prednisolone | Active Comparator |
| |
| Placebo | Placebo Comparator |
| |
| Solution Placebo | Sham Comparator |
| |
| PF-04171327 Tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04171327 | Drug | PF-0417327 will be provided as an oral solution administered at doses of 1, 3, 10 and 30 mg. If an additional cohort is required, the dose selected will not exceed 100 mg. Solution will be administered once daily for 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of multiple doses of PF-04171327 | 14 days | |
| Determination of pharmacokinetic parameters of PF-04171327 after multiple doses | 14 days | |
| Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers | 14 days | |
| Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacodynamic effects of prednisolone | 14 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 | Brussels | 1070 | Belgium |
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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 |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Prednisolone | Drug | Oral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days |
|
| Placebo | Drug | Tablets similar in appearance to prednisolone will be administered once daily for 14 days. |
|
| Placebo Solution | Drug | Placebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days. |
|
| PF-04171327 Tablet | Drug | A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study. |
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |