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

Novartis

Status and phase

Completed

Phase 1

Conditions

Hepatic Impairment

Treatments

Drug: Iloperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01529294

CILO522D2401

Details and patient eligibility

About

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

Enrollment

90 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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