The purpose of the study is primarily to determine the safety and toleration and pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days. Dosing will either be administered twice or three times daily. Secondary objectives will be to investigate the PK of an alternative formulation of PF-05089771 and the effect of food on the PK of PF-05089771.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
PF-05089771 will be dosed as a suspension twice daily
PF-05089771 will be dosed as a suspension twice daily
PF-05089771 will be dosed as a suspension either twice or thrice daily
Pfizer Investigational Site
Brussels, Belgium
Number of participants with adverse events as a measure of safety and tolerability of PF-05089771
Time frame: Days 1-16
Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)
Time frame: Days 1-16
Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)
Time frame: Days 1-16
AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL)
Time frame: Days 1-16
Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose
Time frame: Days 14-16
AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)
Time frame: Days 14-16
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PF-05089771 will be dosed as a suspension either twice or thrice daily