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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals
• Treatments: Iloperidone

Criteria

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.