Status:
COMPLETED
Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
Lead Sponsor:
Pfizer
Conditions:
Obesity
Hepatic Insufficiency
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect its elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time...
Eligibility Criteria
Inclusion
- Healthy:Matched for age (± 5 years), weight (± 10 kg), and gender (±2 subjects per gender)
- Subjects with hepatic disease: 1. mild impairment (child-pugh score 5-6), moderate (child-pugh score 7-9). 2. stable hepatic disease: no changes in the last 30 days. 3. stable dose of medication and/or treatment.
Exclusion
- All subjects: Non-prescribed use of drugs of abuse/recreational drugs; recent treatment with experimental drugs or herbal experiments; ECG and blood pressure falling outside of protocol-specified limits; history of regular tobacco use exceeding protocol-specified limits
- Normal subjects: medically important health conditions; recent use of prescription or non-prescription medications; history of regular alcohol use exceeding protocol-specified limits
- Subjects with hepatic disease: child-puge score greater than 9; hepatic carcinoma and hepatorenal syndrome;Undergone porta-caval shunt surgery; History of GI hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to study entry; significant hepatic encephalopathy; severe ascites and/or pleural effusion; Positive blood alcohol test/alcohol breathalyzer at screening or on Day 0.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00645021
Start Date
April 1 2008
End Date
October 1 2008
Last Update
August 27 2009
Active Locations (2)
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1
Pfizer Investigational Site
Miami, Florida, United States, 33169
2
Pfizer Investigational Site
Orlando, Florida, United States, 32809