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Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics

NCT ID: NCT00692341

Last Updated: 2012-04-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hepatic Function - Mild Impairment

Subjects with mild hepatic impairment (Child Pugh class A, score 5-6)

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.

Hepatic Function - Moderate Impairment

Subjects with moderate hepatic impairment(Child Pugh class B,score 7-9)

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.

Hepatic Function - Normal

Group 1

1\) subjects with normal hepatic function

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.

Interventions

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AG-013736

Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.

Intervention Type DRUG

AG-013736

Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.

Intervention Type DRUG

AG-013736

Single oral 5-mg dose of AG-013736, administered as a film-coated, immediate-release tablet.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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A4061036

Identifier Type: -

Identifier Source: org_study_id

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