Overview

Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers

Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
Summary
This study aims to determine the pharmacokinetic profile and the tolerability of iloperidone in subjects with mild or moderate hepatic impairment comparatively to healthy matched subjects
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Iloperidone
Criteria
Inclusion Criteria:

- Inclusion criteria (all subjects):

- Caucasian subjects

- Inclusion criteria (hepatic impaired subjects):

- subjects with physical signs consistent with a clinical diagnosis of stable liver
disease, which has been confirmed by imaging techniques, ultrasound, Magnetic
Resonance Imaging or Computed Tomogram within 3 months of screening, and a creatinine
clearance > 50 mL/min (based on Cockroft and Gault formula).

- Inclusion criteria (healthy volunteers):

- good general health

- matched by age, gender, smoking status, Body Mass Index, and CYP2D6 phenotype to
hepatic impaired subjects.

Exclusion Criteria:

- Exclusion criteria (all subjects):

- Subjects who report smoking a pipe, cigars or more than 20 cigarettes per day .

- History of drug abuse as defined in Diagnostic and Statistical Manual of Mental
Disorders, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior
to screening

- History of first-dose response/syncope to alpha1-blocking agents

- Exclusion criteria (Hepatic impaired subjects):

- Patients with symptoms or 6 months past history of encephalopathy.

- Patients with clinical evidence of moderate-severe ascites.

- Patients having a previous surgical porto-systemic shunt.

- Exclusion criteria (Healthy volunteers):

- History of alcohol abuse prior to dosing, or evidence of such abuse during screening.

- Pulse Rate > 200 msec

Other protocol-defined inclusion/exclusion criteria may apply