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

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

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 Overview

• Status: Completed
• Conditions: Hepatic Insufficiency; Obesity
• Intervention / Treatment: Drug: CP-945,598; Drug: CP-945,598; Drug: CP-945,598

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33169
      • Pfizer Investigational Site
    • Orlando, Florida, United States, 32809
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Adverse event monitoring throughout duration of the study	14 days
Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: March 21, 2008
• First Submitted That Met QC Criteria: March 21, 2008
• First Posted (Estimate): March 27, 2008

Study Record Updates

• Last Update Posted (Estimate): August 27, 2009
• Last Update Submitted That Met QC Criteria: August 26, 2009
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency
• Other Study ID Numbers: A5351029