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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hepatic Insufficiency; Obesity

Treatments: Drug: CP-945,598

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645021

A5351029

Details and patient eligibility

About

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 course of drug concentrations in the body), safety, and tolerability of CP-945,598 in patients with mild and moderate hepatic impairment and healthy control subjects.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Mild hepatic function

Experimental group

Treatment:

Drug: CP-945,598

Drug: CP-945,598

Drug: CP-945,598

Moderate hepatic function

Experimental group

Treatment:

Drug: CP-945,598

Drug: CP-945,598

Drug: CP-945,598

Normal hepatic function

Experimental group

Treatment:

Drug: CP-945,598

Drug: CP-945,598

Drug: CP-945,598