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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HEPATITIS C (HCV)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

PF-868554

Intervention Type DRUG

200 mg, Child-Pugh Class A

B

Group Type EXPERIMENTAL

PF-868554

Intervention Type DRUG

200 mg, Child-Pugh Class B

C

200 mg

Group Type EXPERIMENTAL

PF-868554

Intervention Type DRUG

200 mg, healthy volunteers

Interventions

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PF-868554

200 mg, Child-Pugh Class A

Intervention Type DRUG

PF-868554

200 mg, Child-Pugh Class B

Intervention Type DRUG

PF-868554

200 mg, healthy volunteers

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes