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

Phase 1

Not yet recruiting

• Conditions: Schizophrenia; Bipolar I Disorder
• Interventions: Drug: VHX-896 and iloperidone; Drug: Iloperidone and VHX-896

• Registration Number: NCT06494397
• Lead Sponsor: Vanda Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A: VHX-896 then iloperidone	VHX-896 and iloperidone	-
Sequence B: Iloperidone then VHX-896	Iloperidone and VHX-896	-

Primary Outcome Measures

Name	Time	Method
Bioequivalence between VHX-896 tablets relative to iloperidone tablets	12 hours	As measured by plasma concentrations

Secondary Outcome Measures

Name	Time	Method
Assessment of safety and tolerability of VHX-896 and iloperidone	24 days	As measured by spontaneous reporting of adverse events (AEs).

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Marlton, New Jersey, United States