A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia
- Registration Number
- NCT04712734
- Lead Sponsor
- Vanda Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Iloperidone Iloperidone -
- Primary Outcome Measures
Name Time Method Assessment of safety and tolerability of repeat-dosing of iloperidone given as a long-acting injection. 24 weeks As measured by spontaneous reporting of adverse events (AEs).
Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection. 24 weeks As measured by plasma concentrations.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanda Investigational Site
🇺🇸Marlton, New Jersey, United States