Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions

Completed · Phase 1

Conditions studied: Schizophrenia, Bipolar I Disorder

In brief

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.

Key facts

Study ID

NCT06494397

Run by

Vanda Pharmaceuticals

People needed

26

Starts

2024-07-11

Expected to finish

2024-10-24

Last updated by the study team

2025-09-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Vanda Investigational Site — Los Alamitos, California, United States
• Vanda Investigational Site — Gaithersburg, Maryland, United States
• Vanda Investigational Site — Marlton, New Jersey, United States

Full record on ClinicalTrials.gov

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