We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00651027
First Posted: April 2, 2008
Last Update Posted: January 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
March 31, 2008
April 2, 2008
January 3, 2014
February 2008
September 2008   (Final data collection date for primary outcome measure)
PK parameters [ Time Frame: 8 day ]
Same as current
Complete list of historical versions of study NCT00651027 on ClinicalTrials.gov Archive Site
safety and tolerability [ Time Frame: 8days ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HEPATITIS C (HCV)
  • Drug: PF-868554
    200 mg, Child-Pugh Class A
  • Drug: PF-868554
    200 mg, Child-Pugh Class B
  • Drug: PF-868554
    200 mg, healthy volunteers
  • Experimental: A
    Intervention: Drug: PF-868554
  • Experimental: B
    Intervention: Drug: PF-868554
  • Experimental: C
    200 mg
    Intervention: Drug: PF-868554
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2008
September 2008   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
18 Years to 62 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00651027
A8121004
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP