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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00651027

Enrollment

Registered

2008-04-02

Start date

2008-02-29

Completion date

2008-09-30

Last updated

2014-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HEPATITIS C (HCV)

Brief summary

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.

Interventions

DRUGPF-868554

200 mg, Child-Pugh Class A

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 62 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame
PK parameters	8 day

Secondary

Measure	Time frame
safety and tolerability	8days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026