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

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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

Key facts

Study ID

NCT01529294

Run by

Novartis Pharmaceuticals

People needed

90

Starts

2010-08-01

Expected to finish

2012-07-01

Last updated by the study team

2013-03-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Anaheim, California, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — South Miami, Florida, United States

Full record on ClinicalTrials.gov

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