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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00651027
First received: March 31, 2008
Last updated: January 2, 2014
Last verified: January 2014

March 31, 2008
January 2, 2014
February 2008
September 2008   (final data collection date for primary outcome measure)
PK parameters [ Time Frame: 8 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00651027 on ClinicalTrials.gov Archive Site
safety and tolerability [ Time Frame: 8days ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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;
Both
18 Years to 62 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00651027
A8121004
No
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