Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554

This study has been completed.

First Received: March 31, 2008 Last Updated: November 21, 2008 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00651027

Purpose

The metabolism of PF-00868554 is primarily mediated by CYP3A, and it is anticipated that hepatic impairment will modify PF-00868554 plasma concentrations. Hence, it is important to determine the impact of varying degrees of hepatic impairment on the pharmacokinetics, safety and toleration of 200 mg PF-00868554 administered as a single-dose.

Condition	Intervention	Phase
HEPATITIS C (HCV)	Drug: PF-868554	Phase I

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	An Open Label Study, To Evaluate The Pharmacokinetics, Safety And Toleration Of A Single Oral Dose Of Pf-00868554 In Subjects With Hepatic Impairment To Subjects With Normal Hepatic Function

Further study details as provided by Pfizer:

Primary Outcome Measures:

PK parameters [ Time Frame: 8 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety and tolerability [ Time Frame: 8days ] [ Designated as safety issue: Yes ]

Enrollment:	24
Study Start Date:	February 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: PF-868554 200 mg, Child-Pugh Class A
B: Experimental	Drug: PF-868554 200 mg, Child-Pugh Class B
C: Experimental 200 mg	Drug: PF-868554 200 mg, healthy volunteers

Eligibility

Ages Eligible for Study:	18 Years to 62 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or females subjects of non-childbearing potential between the ages of 18 and 62 years of age, inclusive;
Body Mass Index (BMI) of approximately 18 to 35 kg/m2; and a total body weigh >50 kg (110 lbs);

Exclusion Criteria:

Subjects with Class C classification (Severe - Child-Pugh Scores greater than 10);
Severe ascites and/or pleural effusion;
Had a transplanted kidney, heart or liver;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651027

Locations

United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
Pfizer Investigational Site
Anaheim, California, United States, 92804
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8121004
Study First Received:	March 31, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00651027 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases

Digestive System Diseases
Hepatitis, Viral, Human
Hepatitis C

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases

Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Hepatitis C

ClinicalTrials.gov processed this record on May 07, 2009