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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

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NCT00651027

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HEPATITIS C (HCV)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-62 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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;

NCT00651027
Pfizer
Completed
Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554

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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
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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