NCT06494397CompletedPhase 1
Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions
Crossover Bioequivalence Study of 12 mg VHX-896 and Iloperidone Tablets Under Steady-State Conditions
Source: ClinicalTrials.gov · Last updated 19 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 2 Jul 2024
- Start date
- 11 Jul 2024
- Primary completion date
- 24 Oct 2024
- Lead sponsor
- Vanda Pharmaceuticals
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT06494397
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 26
- From 11 Jul 2024 to the primary completion date, 24 Oct 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Gaithersburg | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Marlton | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.