CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal (kidney) function can affect their elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety and tolerability of CP-945,598 in patients with severe renal impairment and healthy control subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Administration of CP-945,598 in subjects with normal renal function.
Administration of CP-945,598 in subjects with severe renal impairment.
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Miami, Florida, United States
Measurement of drug and metabolite concentrations in serum from blood samples collected at various times over 24 hour dosing interval on Days 1 & 14, before daily dose on days 2, 5-7, 13, following stopping of drug treatment on days 15-18, 21,
Time frame: 14 days
28, 35
Time frame: 14 days
Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 2, 7, and 14
Time frame: 14 days
ECGs on Days 1,7 and 14
Time frame: 14 days
Safety laboratory tests (Chemistry, hematology, urinalysis) on Days 2, 7, 14 and 35
Time frame: 14 days
Adverse event monitoring throughout duration of the study
Time frame: 14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.