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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Iloperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT04712734

VP-VYV-683-1005

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Iloperidone

Experimental group

Treatment:

Drug: Iloperidone