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

Pfizer

Status and phase: Completed; Phase 1

Conditions: HEPATITIS C (HCV)

Treatments: Drug: PF-868554

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651027

A8121004

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 62 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

A

Experimental group

Treatment:

Drug: PF-868554

Drug: PF-868554

Drug: PF-868554

B

Experimental group

Treatment:

Drug: PF-868554

Drug: PF-868554

Drug: PF-868554

C

Experimental group

Description:

200 mg

Treatment:

Drug: PF-868554

Drug: PF-868554

Drug: PF-868554