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

HEPATITIS C (HCV) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651027
• Other study ID #: A8121004
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2008
• Last updated: January 2, 2014
• Start date: February 2008
• Est. completion date: September 2008

Study information

• Verified date: January 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 62 Years

Eligibility

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;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HEPATITIS C (HCV)

Intervention

Drug:
• PF-868554
200 mg, Child-Pugh Class A
• PF-868554
200 mg, Child-Pugh Class B
• PF-868554
200 mg, healthy volunteers

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters		8 day	No
Secondary	safety and tolerability		8days	Yes

External Links

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