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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
PF-05089771 will be dosed as a suspension twice daily (BID)
PF-05089771 will be dosed as a suspension twice daily (BID)
PF-05089771 will be dosed as a suspension twice daily (BID)
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, 4 and 14
Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)
Time frame: Days 1, 6 and 14
AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL)
Time frame: Days 1, 6 and 14
Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose
Time frame: day 14 PK samples collected only for 48 hours
AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)
Time frame: Days 14, over 48 hours of PK samples collection
Daily pain score throughout the treatment period using an 11-point Numeric Rating Scale (NRS).
Time frame: Days 14, every day over 24 hours
Daily time to ascend and descend stairs.
Time frame: Days 14, every day over 24 hours
Daily pain following stair climbing and descending
Time frame: Days 14, every day over 24 hours
Daily time for self paced walk
Time frame: Days 14, every day over 24 hours
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PF-05089771 will be dosed as a suspension twice daily (BID)
PF-05089771 will be dosed as a suspension BID
Daily pain following self paced walk.
Time frame: Days 14, every day over 24 hours