Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in 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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two tablets, VHX-896 and Iloperidone, to see if they work the same way in healthy people. Healthy volunteers are used to ensure clear results. The study measures how similarly the body absorbs and processes both tablets. Iloperidone is a medication approved several years ago for the treatment of schizophrenia in adults.

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.

What safety data exists for Iloperidone (also known as VHX-896) in humans?

Iloperidone has been studied for the treatment of schizophrenia, and it is considered to have a safety profile similar to other antipsychotic medications. It is known to have moderate affinity for certain brain receptors, which may help reduce side effects common with other antipsychotics. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Iloperidone, VHX-896?

Iloperidone is shown to be effective in treating schizophrenia, as it improved symptoms in several large clinical trials compared to a placebo. It was also found to have similar effectiveness to other antipsychotic drugs like haloperidol and risperidone, with fewer motor-related side effects. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

Interventions

• Iloperidone
• VHX-896

Participant Groups

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+

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Iloperidone: in schizophrenia. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Iloperidone (Novartis). [2003]

3. England pubmed.ncbi.nlm.nih.gov

Iloperidone: a new benzisoxazole atypical antipsychotic drug. Is it novel enough to impact the crowded atypical antipsychotic market? [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of iloperidone in the treatment of schizophrenia: initial phase 3 studies. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Iloperidone: chemistry, pharmacodynamics, pharmacokinetics and metabolism, clinical efficacy, safety and tolerability, regulatory affairs, and an opinion. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Iloperidone for the treatment of schizophrenia. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Safety profile of iloperidone in the treatment of schizophrenia. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Iloperidone: A new drug for the treatment of schizophrenia. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Iloperidone (Hoechst Marion Roussel Inc). [2005]

10. India pubmed.ncbi.nlm.nih.gov

Iloperidone redux: a dissection of the Drug Approval Package for this newly commercialised second-generation antipsychotic. [2017]