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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-07-31

Brief Summary

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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

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Iloperidone

Eligible subjects receive a single oral dose of 2 mg iloperidone as a tablet

Group Type EXPERIMENTAL

Iloperidone

Intervention Type DRUG

Interventions

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Iloperidone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Caucasian 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).
* good general health
* matched by age, gender, smoking status, Body Mass Index, and CYP2D6 phenotype to hepatic impaired subjects.

Exclusion Criteria

* 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
* 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.
* History of alcohol abuse prior to dosing, or evidence of such abuse during screening.
* Pulse Rate \> 200 msec

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes