The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single dose of PF-04991532 in healthy adult subjects with and without co-administration of cyclosporine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
a single dose of 150 mg PF-04991532, fasted
a single dose of 150 mg PF-04991532 + a single dose of 600 mg cyclosporine, fasted
Pfizer Investigational Site
Brussels, Belgium
Area under the plasma concentration versus time profile (AUC)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Max observed plasma concentration (Cmax)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Time of Cmax (Tmax)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Terminal elimination half-life (t1/2)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Total amount of unchanged drug excreted in the urine over 24 hours (Ae24)
Time frame: 0-8, and 8-24hr postdose
Renal clearance (CLR)
Time frame: 0-24hr
Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose (Ae24(% excreted))
Time frame: 0-24hr
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