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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00645021

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Hepatic Insufficiency	Drug: CP-945,598 Drug: CP-945,598 Drug: CP-945,598	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Mild hepatic function

Drug: CP-945,598

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

Experimental: Moderate hepatic function

Drug: CP-945,598

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

Experimental: Normal hepatic function

Drug: CP-945,598

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Miami	Florida	United States	33169
2	Pfizer Investigational Site	Orlando	Florida	United States	32809

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00645021

Other Study ID Numbers:

A5351029

First Posted:

Mar 27, 2008

Last Update Posted:

Aug 27, 2009

Last Verified:

Nov 1, 2008

Additional relevant MeSH terms:

Hepatic Insufficiency

Liver Failure

Study Results

No Results Posted as of Aug 27, 2009