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Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Miami, Florida, 33169 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity, Hepatic Insufficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00645021
Pfizer
Completed
Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug

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