Pharmacokinetic Study of VHX-896 and Iloperidone Tablets... | NCT06494397

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

NCT06494397

Sponsor

Vanda Pharmaceuticals

Status

Completed

Last Update Posted

Sep 19, 2025Actual

Enrollment

26Actual

Phase

Phase 1

Conditions

Schizophrenia
Bipolar I Disorder

Interventions

VHX-896 and iloperidone
Iloperidone and VHX-896

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2024Actual

Primary Completion Date

Oct 24, 2024Actual

Completion Date

Oct 24, 2024Actual

First Submitted Date

Jul 2, 2024

First Submission Date that Met QC Criteria

Jul 2, 2024

First Posted Date

Jul 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2025

Last Update Posted Date

Sep 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence A: VHX-896 then iloperidone	Experimental		Drug: VHX-896 and iloperidone
Sequence B: Iloperidone then VHX-896	Experimental		Drug: Iloperidone and VHX-896

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VHX-896 and iloperidone	Drug	oral tablet	Sequence A: VHX-896 then iloperidone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bioequivalence between VHX-896 tablets relative to iloperidone tablets	As measured by plasma concentrations	12 hours

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanda Investigational Site		Los Alamitos	California	90720	United States
Vanda Investigational Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C081732	iloperidone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided