Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hepatic Insufficiency

Treatments: Drug: AG-013736

Study type: Interventional

Funder types: Industry

Identifiers

NCT00692341

A4061036

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 3 patient groups

Hepatic Function - Mild Impairment

Experimental group

Description:

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

Treatment:

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Hepatic Function - Moderate Impairment

Experimental group

Description:

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

Treatment:

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736

Hepatic Function - Normal

Experimental group

Description:

Group 1 1) subjects with normal hepatic function

Treatment:

Drug: AG-013736

Drug: AG-013736

Drug: AG-013736