A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia

Vanda Pharmaceuticals42 enrolled

Overview

This is a multicenter, open-label, adaptive, repeat-dose study to evaluate the safety, tolerability, and pharmacokinetics of iloperidone long-acting injection (LAI) in patients with schizophrenia.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

IloperidoneDRUG

oral tablet, long-acting injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Willing and able to provide written informed consent. * Male or female patients 18 to 65 years of age (inclusive). * Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for at least 1 year. * Symptomatically stable within the past two months. Exclusion Criteria: * Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. * Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs. * Pregnant or nursing (lactating) women. * A positive test for drugs of abuse.

Locations (3)

Vanda Investigational Site

Garden Grove, California, United States

Vanda Investigational Site

Gaithersburg, Maryland, United States

Vanda Investigational Site

Marlton, New Jersey, United States

Outcomes

Primary Outcomes

Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection.

As measured by plasma concentrations.

Time frame: 24 weeks

Assessment of safety and tolerability of repeat-dosing of iloperidone given as a long-acting injection.

As measured by spontaneous reporting of adverse events (AEs).

Time frame: 24 weeks

Data from ClinicalTrials.gov

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