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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
78
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.
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
Tablets similar in appearance to prednisolone will be administered once daily for 14 days.
Pfizer Investigational Site
Brussels, Belgium
Safety and tolerability of multiple doses of PF-04171327
Time frame: 14 days
Determination of pharmacokinetic parameters of PF-04171327 after multiple doses
Time frame: 14 days
Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers
Time frame: 14 days
Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet
Time frame: 1 day
To characterize the pharmacodynamic effects of prednisolone
Time frame: 14 days
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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.
A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.