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

Launched by VANDA PHARMACEUTICALS · Jul 2, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to study two medications, VHX-896 and iloperidone, in patients with schizophrenia or bipolar I disorder. The main goal is to understand how these drugs work in the body and to see how safe they are for people taking them consistently. Researchers will look at how the body absorbs, distributes, and eliminates these medications, as well as how they affect symptoms of the conditions being studied.

To participate in this trial, individuals need to be between 18 and 65 years old and have a diagnosis of schizophrenia or bipolar I disorder. It's important that they are currently stable and on a regular treatment plan with an oral antipsychotic medication for at least three months. Participants can expect to undergo assessments to monitor their health and the effects of the medications. This trial is not yet recruiting participants, so there will be more information available in the future about how to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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