Schizophrenia
Conditions
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.
Interventions
DRUGIloperidone
oral tablet, long-acting injection
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection. | 24 weeks | As measured by plasma concentrations. |
| 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). |
Countries
United States
Outcome results
None listed