VHX-896 vs Iloperidone for Healthy Volunteers

Overseen By Vanda Pharmaceuticals Inc.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Vanda Pharmaceuticals

Disqualifiers: Drug abuse, Significant illness, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 96 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new tablet, VHX-896, acts similarly to the existing antipsychotic medication iloperidone in healthy volunteers. The goal is to determine if both treatments yield similar results under controlled conditions. Participants will receive both treatments in different sequences to compare their effects. Individuals who are generally healthy and have no significant medical or mental health issues may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy volunteers, it's possible that you may need to pause certain medications. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that iloperidone is generally safe for humans. In a study with adults who have schizophrenia, patients managed fixed doses over four weeks without major problems. However, like many medications, iloperidone may cause some side effects.

For VHX-896, which is similar to iloperidone, safety studies have been conducted. These studies examined how the body absorbs and reacts to both VHX-896 and iloperidone. The results suggest that VHX-896 is also well-tolerated by those who have taken it.

Since this trial is in its early phase, it primarily focuses on understanding how the body processes these treatments. Such trials are crucial to determine if a treatment is safe enough for larger studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about VHX-896 because it aims to match the effectiveness of iloperidone, a standard treatment for schizophrenia, but with potential benefits. One key feature of VHX-896 is its potential for improved bioavailability, meaning the body might absorb it more effectively, possibly leading to quicker or more consistent results. This could be a game-changer for patients who need fast and reliable symptom management. Additionally, if VHX-896 reduces side effects compared to current options, it could offer a more comfortable experience for users.

What evidence suggests that this trial's treatments could be effective?

This trial will compare the effectiveness of iloperidone and VHX-896 in treating schizophrenia. Research has shown that iloperidone significantly improves symptoms compared to a placebo, with many patients experiencing less severe symptoms. Meanwhile, VHX-896 is under study for similar benefits. Although limited information exists about its effectiveness in people, early results suggest potential effectiveness. Participants in this trial will receive either Sequence A: VHX-896 followed by iloperidone, or Sequence B: iloperidone followed by VHX-896. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

Have a Body Mass Index (BMI) of > 18.0 and < 30.0 kg/m2; (BMI = weight (kg)/ [height (m)]2).

Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.

Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of VHX-896 or iloperidone in a two-period crossover design

96 hours

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

17 days

What Are the Treatments Tested in This Trial?

Interventions

• Iloperidone
• VHX-896

How Is the Trial Designed?

Group I: Sequence B: Iloperidone then VHX-896 Experimental Treatment 1 Intervention

Group II: Sequence A: VHX-896 then iloperidone Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials

68

Recruited

19,900+

Published Research Related to This Trial

Iloperidone has been shown to be effective in treating schizophrenia, with multiple dosing groups demonstrating significant improvements over placebo in three randomized, double-blind studies involving 1943 patients.

Iloperidone was associated with a lower risk of motor-related side effects compared to other antipsychotics like risperidone and haloperidol, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of iloperidone in the treatment of schizophrenia: initial phase 3 studies. Potkin, SG., Litman, RE., Torres, R., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38236020/

Efficacy and Safety of Iloperidone in Bipolar Mania Iloperidone demonstrated significant improvement versus placebo at week 4 for the primary and secondary endpoints. Differences in the least- ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21700430/

Efficacy of iloperidone in schizophrenia: a PANSS five- ... Iloperidone demonstrated positive treatment effects on these newly derived PANSS factors. The 10-16 mg and 20-24 mg dose groups had similar efficacy on the ...

3. dovepress.com dovepress.com/article/download/15960

Long-term efficacy and safety of iloperidone: an update Kane et al reported on the long-term efficacy data from three iloperidone trials.13 Patients who obtained $20% reduction in their PANSS-T score after completing ...

4. fanaptpro.com fanaptpro.com/atypical-antipsychotic-efficacy

Atypical Antipsychotic Efficacy Patients taking Fanapt® at both high and low doses demonstrated significant reductions from baseline in BPRS score at Day 421: The active-control antipsychotic ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920996411002945

Efficacy of iloperidone in schizophrenia: A PANSS five ... We conducted a 5-factor analysis for evaluating the efficacy of iloperidone vs. placebo across these different domains in the treatment of schizophrenia.

6. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/27806m.pdf

Safety Data Sheet Safety Data Sheet acc. to OSHA HCS. Date of issue: 09/16/2025. Revision date 09/16/2025. Trade name: Iloperidone metabolite P88. (Contd. from ...

7. file.medchemexpress.com file.medchemexpress.com/batch_PDF/HY-17410/Iloperidone-SDS-MedChemExpress.pdf

Safety Data Sheet Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Refer to protective measures listed in ...

8. chemicalbook.com chemicalbook.com/msds/iloperidone.htm

ILOPERIDONE - Safety Data Sheet Precautions for safe handling. Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Provide appropriate exhaust ventilation at places where ...

9. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/22957m.pdf

Safety Data Sheet UN "Model Regulation": UN 2811 TOXIC SOLID, ORGANIC, N.O.S.. (ILOPERIDONE), 6.1, I. 15 Regulatory information. · Safety, health and ...

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2016/022192s017lbl.pdf

FANAPT (iloperidone) tablets - accessdata.fda.gov Data from a 4- week, fixed-dose study in adult subjects with schizophrenia, in which fasting blood samples were drawn,are presented in Table 1. Table 1 ...