SchizophreniaPhase 1NCT06494397
Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions
A Phase 1 study testing VHX-896 and iloperidone and Iloperidone and VHX-896 in people with Schizophrenia and Bipolar I Disorder, run by Vanda Pharmaceuticals at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Bipolar I Disorder
- What is being tested?
- VHX-896 and iloperidone and Iloperidone and VHX-896
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jul 2024to 24 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanda Investigational Site
Gaithersburg, Maryland, 20877
Vanda Investigational Site
Los Alamitos, California, 90720
Vanda Investigational Site
Marlton, New Jersey, 08053
About this study
Official title: Crossover Bioequivalence Study of 12 mg VHX-896 and Iloperidone Tablets Under Steady-State Conditions
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.
- Conditions
- Schizophrenia, Bipolar I Disorder
- Being tested
- VHX-896 and iloperidone, Iloperidone and VHX-896
- Keywords
- Iloperidone, VHX-896
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VHX-896 and iloperidoneDrug
oral tablet
Iloperidone and VHX-896Drug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: VHX-896 then iloperidone | Experimental | Not described Receives: Drug: VHX-896 and iloperidone |
| Sequence B: Iloperidone then VHX-896 | Experimental | Not described Receives: Drug: Iloperidone and VHX-896 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence between VHX-896 tablets relative to iloperidone tablets
As measured by plasma concentrations
Measured: 12 hours
Secondary outcomes (1)
Assessment of safety and tolerability of VHX-896 and iloperidone
As measured by spontaneous reporting of adverse events (AEs).
Measured: 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start11 Jul 2024
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494397
- Sponsor's protocol ID
- VP-VHX-896-1103
- Status last verified
- Sep 2025
- First submitted
- 2 Jul 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover Bioequivalence Study of 12 mg VHX-896 and Iloperidone Tablets Under Steady-State Conditions
- ClinicalTrials.gov ID
- NCT06494397
- Acronym / sponsor ID
- VP-VHX-896-1103
- Conditions
- Schizophrenia, Bipolar I Disorder
- Keywords
- Iloperidone, VHX-896
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: VHX-896 then iloperidone | Experimental | Drug: VHX-896 and iloperidone |
| Sequence B: Iloperidone then VHX-896 | Experimental | Drug: Iloperidone and VHX-896 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VHX-896 and iloperidoneoral tablet | Drug | Sequence A: VHX-896 then iloperidone |
| Iloperidone and VHX-896oral tablet | Drug | Sequence B: Iloperidone then VHX-896 |
Primary outcome
Bioequivalence between VHX-896 tablets relative to iloperidone tablets
Time frame: 12 hours
As measured by plasma concentrations
1 secondary outcome
Assessment of safety and tolerability of VHX-896 and iloperidone
Time frame: 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VHX-896 and iloperidone and Iloperidone and VHX-896 in people with Schizophrenia and Bipolar I Disorder, run by Vanda Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence between VHX-896 tablets relative to iloperidone tablets (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.