A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
10 mg (2 x 5 mg tablets), single dose
10 mg (2 x 5 mg tablets), single dose
10 mg (2 x 5 mg tablets), single dose
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
New Orleans, Louisiana, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Renal Clearance (CL R)
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.
Time frame: 0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose
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10 mg (2 x 5 mg tablets), single dose