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

Pfizer24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity Hepatic Insufficiency

Interventions

CP-945,598DRUG

Administration of CP-945,598 in subjects with mild hepatic function

CP-945,598DRUG

Administration of CP-945,598 in subjects with moderate hepatic function

CP-945,598DRUG

Administration of CP-945,598 in subjects with normal hepatic function

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Pfizer Investigational Site

Miami, Florida, United States

Pfizer Investigational Site

Orlando, Florida, United States

Outcomes

Primary Outcomes

Measurement of drug and metabolite concentrations in serum collected at various times over 24 hour dosing interval on Days 1 and 14, before daily dose on days 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, and 35

Time frame: 14 days

Secondary Outcomes

Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35

Time frame: 14 days

Adverse event monitoring throughout duration of the study

Time frame: 14 days

Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14

Time frame: 14 days

ECGs on Days 1, 7, and 14

Time frame: 14 days

Data from ClinicalTrials.gov

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