CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare the time course of drug concentrations in the body, safety and tolerability of CP-945,598 given with or without grapefruit juice in healthy obese/overweight subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Subjects take CP-945,598 alone for 21 days
Subjects take CP-945,598 from Days 1 to 7, then take CP-945,598 and Grapefruit Juice from Days 8 to 21
Pfizer Investigational Site
New Haven, Connecticut, United States
Measurement of durg and metabolite concentrations in serum from blood sampling collected at various times over 24 hours dosing interval on Day 7 and 21, before dosing on days 5,6, 12, 13, 14, 19 and 20.
Time frame: 21 days
Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22
Time frame: 21 days
Adverse event monitoring throughout duration of the study
Time frame: 21 days
Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21.
Time frame: 2 days
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