VHX-896 vs Iloperidone for Healthy Volunteers
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.12345Why 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-896.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of VHX-896 or iloperidone in a two-period crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Iloperidone
- VHX-896
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanda Pharmaceuticals
Lead Sponsor
Published Research Related to This Trial
Citations
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- ...
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 ...
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 ...
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 ...
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.
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 ...
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file.medchemexpress.com
file.medchemexpress.com/batch_PDF/HY-17410/Iloperidone-SDS-MedChemExpress.pdfSafety Data Sheet
Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Refer to protective measures listed in ...
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 ...
Safety Data Sheet
UN "Model Regulation": UN 2811 TOXIC SOLID, ORGANIC, N.O.S.. (ILOPERIDONE), 6.1, I. 15 Regulatory information. · Safety, health and ...
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 ...
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