Bipolar I Disorder, Schizophrenia
Conditions
Keywords
Iloperidone, VHX-896
Brief summary
Study to compare the pharmacokinetics and pharmacodynamics of VHX-896 and iloperidone and evaluate the safety and tolerability of VHX-896 and iloperidone in patients with schizophrenia or bipolar I disorder under steady state conditions.
Interventions
oral tablet
oral tablet
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients 18 to 65 years of age (inclusive) * Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type, according to the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition, Text Revision (DSM-5-TR) * Patients must be symptomatically stable and on a stable treatment with an oral atypical antipsychotic at an adequate dose (3 months prior to enrollment) and not suffer from acute increase of their psychosis or be hospitalized within the past 2 months
Exclusion criteria
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes * Cytochrome P450 2D6 (CYP2D6) poor metabolizers and use of prescription medication or OTC medication that strongly inhibits CYP2D6 or CYP3A4 or induces CYP3A4 within 5 half-lives of baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioequivalence between VHX-896 tablets relative to iloperidone tablets | 12 hours | As measured by plasma concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of safety and tolerability of VHX-896 and iloperidone | 24 days | As measured by spontaneous reporting of adverse events (AEs). |
Countries
United States
Outcome results
None listed