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

Phase 1

Completed

• Conditions: Obesity; Hepatic Insufficiency
• Interventions: Drug: CP-945,598

• Registration Number: NCT00645021
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-27
• Study Start: 2008-04
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2008-11
• Disposition First Posted: 2009-08-13
• Disposition First Submitted: 2009-08-26
• Disposition First Submitted QC: 2009-08-26
• Last Update Submitted: 2009-08-26
• Last Update Posted: 2009-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild hepatic function	CP-945,598	-
Moderate hepatic function	CP-945,598	-
Normal hepatic function	CP-945,598	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Orlando, Florida, United States