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
1 other identifier
interventional
26
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 schizophrenia
Started Jul 2024
Shorter than P25 for phase_1 schizophrenia
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2024
CompletedFirst Posted
Study publicly available on registry
July 10, 2024
CompletedStudy Start
First participant enrolled
July 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2024
CompletedSeptember 19, 2025
September 1, 2025
4 months
July 2, 2024
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bioequivalence between VHX-896 tablets relative to iloperidone tablets
As measured by plasma concentrations
12 hours
Secondary Outcomes (1)
Assessment of safety and tolerability of VHX-896 and iloperidone
24 days
Study Arms (2)
Sequence A: VHX-896 then iloperidone
EXPERIMENTALSequence B: Iloperidone then VHX-896
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Vanda Investigational Site
Los Alamitos, California, 90720, United States
Vanda Investigational Site
Gaithersburg, Maryland, 20877, United States
Vanda Investigational Site
Marlton, New Jersey, 08053, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2024
First Posted
July 10, 2024
Study Start
July 11, 2024
Primary Completion
October 24, 2024
Study Completion
October 24, 2024
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share