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Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Miami, Florida, 33169 United States
Contact
1-800-718-1021
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

NCT00692341
Pfizer
Completed
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics

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Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
A Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Subjects With Impaired Hepatic Function
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatic Insufficiency
Drug: AG-013736
Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
  • 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
Not Provided


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

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00692341
A4061036
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

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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1-800-718-1021

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Contact

[email protected]



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