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

Completed · Phase 1

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT04712734

Run by

Vanda Pharmaceuticals

People needed

42

Starts

2021-01-13

Expected to finish

2022-08-30

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Vanda Investigational Site — Garden Grove, California, United States
• Vanda Investigational Site — Gaithersburg, Maryland, United States
• Vanda Investigational Site — Marlton, New Jersey, United States

Full record on ClinicalTrials.gov

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