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

Study Overview
=================
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 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.

Official Title
-----------------
A Phase 1, Open-Label, Parallel Group, Multiple-Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of CP-945,598 Administered To Subjects With Impaired And Normal Hepatic Function

Conditions
-----------------
Obesity, Hepatic Insufficiency

Intervention / Treatment
-----------------
* Drug: CP-945,598
* Drug: CP-945,598
* Drug: CP-945,598


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild hepatic function<br> | Drug: CP-945,598<br>* Administration of CP-945,598 in subjects with mild hepatic function<br>|
| Experimental: Moderate hepatic function<br> | Drug: CP-945,598<br>* Administration of CP-945,598 in subjects with moderate hepatic function<br>|
| Experimental: Normal hepatic function<br> | Drug: CP-945,598<br>* Administration of CP-945,598 in subjects with normal hepatic function<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35 |  | 14 days | 
| Adverse event monitoring throughout duration of the study |  | 14 days | 
| Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14 |  | 14 days | 
| ECGs on Days 1, 7, and 14 |  | 14 days |