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

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Study Location
Pfizer Investigational Site
Anaheim, California, 92801, United States
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Contact
1-800-718-1021
[email protected]
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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.
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- 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.
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- 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;

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HEPATITIS C (HCV)Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554
NCT00651027
  1. Anaheim, California
  2. Anaheim, California
  3. Miami, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HEPATITIS C (HCV)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: PF-868554
  • Experimental: B
    Intervention: Drug: PF-868554
  • Experimental: C
    200 mg
    Intervention: Drug: PF-868554
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2008)		24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 62 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00651027
Other Study ID Numbers  ICMJE A8121004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2014

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