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Completed

NCT Number: NCT04712734

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanda Investigational Site, Garden Grove, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iloperidone

Drug

oral tablet, long-acting injection

Other names: VYV-683

Primary outcomes

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

    Time frame: 24 weeks

    As measured by plasma concentrations.

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

    Time frame: 24 weeks

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

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

An Open-label, Adaptive, Repeat-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Iloperidone Long-acting Injection (LAI) in Patients With Schizophrenia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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