Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00692341

Purpose

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.

Condition	Intervention	Phase
Hepatic Insufficiency	Drug: AG-013736	Phase I

Drug Information available for: Axitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Subjects With Impaired Hepatic Function

Further study details as provided by Pfizer:

Primary Outcome Measures:

Plasma pharmacokinetics of axitinib following single-dose (5 mg) administration will be assessed by measuring concentration in plasma samples collected through 144 hours after dosing. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Safety of axitinib following single-dose (5 mg) administration will be assessed by monitoring of laboratory tests (hematology, blood chemistry, coagulation, and urinalysis). physical examination, vital signs, ECGs, concomitant medications, and AEs. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

No secondary objectives in this study. Primary endpoints are i) pharmacokinetics and ii) safety [ Time Frame: 12 months from study start ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	May 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Hepatic Function - Mild Impairment: Experimental Subjects with mild hepatic impairment (Child Pugh class A, score 5-6)	Drug: AG-013736 Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
Hepatic Function - Moderate Impairment: Experimental Subjects with moderate hepatic impairment(Child Pugh class B,score 7-9)	Drug: AG-013736 Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.
Hepatic Function - Normal: Experimental Group 1 1) subjects with normal hepatic function	Drug: AG-013736 Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692341

Locations

United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32809
Pfizer Investigational Site
Miami, Florida, United States, 33169

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061036
Study First Received:	June 4, 2008
Last Updated:	December 27, 2008
ClinicalTrials.gov Identifier:	NCT00692341
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

hepatic impairment

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Hepatic Insufficiency

ClinicalTrials.gov processed this record on January 16, 2009