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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Bipolar I Disorder; Schizophrenia

Treatments: Drug: VHX-896 and iloperidone; Drug: Iloperidone and VHX-896

Study type: Interventional

Funder types: Industry

Identifiers

NCT06494397

VP-VHX-896-1103

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Sequence A: VHX-896 then iloperidone

Experimental group

Treatment:

Drug: VHX-896 and iloperidone

Sequence B: Iloperidone then VHX-896

Experimental group

Treatment:

Drug: Iloperidone and VHX-896