1. To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body. 2. To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.
Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function. On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
16
50 mg (two 25 mg capsules), single, oral dose
50 mg (two 25 mg capsules), single, oral dose
50 mg (two 25 mg capsules), single, oral dose
Pfizer Investigational Site
Cypress, California, United States
Pfizer Investigational Site
Miami, Florida, United States
maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)
Time frame: 1 day
amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96)
Time frame: 5 days
PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast),
Time frame: 5 to 17 days depending on cohort
PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2),
Time frame: 5 to 17 days depending on cohort
Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs
Time frame: 5 to 17 days
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50 mg (two 25 mg capsules), single, oral dose