The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.
Detailed Description: Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334. On February 18th 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
RANDOMIZED
Masking
NONE
Enrollment
12
Single 300 mg dose of PD 0332334 immediate release capsules administered orally
Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.
600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.
Pfizer Investigational Site
New Haven, Connecticut, United States
PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf)
Time frame: 4 to 6 days
PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
Time frame: 4 to 6 days
Half-life (t1/2) of PD 0332334
Time frame: 4 to 6 days
Maximum plasma concentration (Cmax) of PD 0332334
Time frame: 4 to 6 days
Evaluate the incidence, duration and severity of adverse events
Time frame: 4 to 6 days
Evaluate the discontinuation due to adverse events
Time frame: 4 to 6 days
Clinical safety labs
Time frame: 4 to 6 days
ECG
Time frame: 4 to 6 days
Vital signs
Time frame: 4 to 6 days
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