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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.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: March 31, 2008
Last updated: January 2, 2014
Last verified: January 2014
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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 ]

Secondary Outcome Measures:
  • safety and tolerability [ Time Frame: 8days ]

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


Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00651027

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
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00651027     History of Changes
Other Study ID Numbers: A8121004
Study First Received: March 31, 2008
Last Updated: January 2, 2014

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases processed this record on September 19, 2017