Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics

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NCT00692341

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Study Location
Pfizer Investigational Site
Miami, Florida, 33169, 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.
Hepatic Insufficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of reduced hepatic function (Child Pugh Classification A or B)

- Body Mass Index of 18-32 kg/m2

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


- History of febrile illness within 5 days prior to first dose


- Any condition possibly affecting drug absorption (e.g. gastrectomy)


- Positive urine drug screen

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
Official Title  ICMJE A Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Subjects With Impaired Hepatic Function
Brief Summary This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.
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 Hepatic Insufficiency
Intervention  ICMJE Drug: AG-013736
Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
Study Arms  ICMJE
  • Experimental: Hepatic Function - Mild Impairment
    Subjects with mild hepatic impairment (Child Pugh class A, score 5-6)
    Intervention: Drug: AG-013736
  • Experimental: Hepatic Function - Moderate Impairment
    Subjects with moderate hepatic impairment(Child Pugh class B,score 7-9)
    Intervention: Drug: AG-013736
  • Experimental: Hepatic Function - Normal

    Group 1

    1) subjects with normal hepatic function

    Intervention: Drug: AG-013736
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: June 4, 2008)		24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of reduced hepatic function (Child Pugh Classification A or B)
  • Body Mass Index of 18-32 kg/m2

Exclusion Criteria:

  • History of febrile illness within 5 days prior to first dose
  • Any condition possibly affecting drug absorption (e.g. gastrectomy)
  • Positive urine drug screen
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older 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 NCT00692341
Other Study ID Numbers  ICMJE A4061036
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 April 2012

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