A Study to Evaluate Iloperidone Long-acting Injection (LA... | NCT04712734

Studies
A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia

NCT04712734

Sponsor

Vanda Pharmaceuticals

Status

Completed

Last Update Posted

Jun 29, 2023Actual

Enrollment

42Actual

Phase

Phase 1

Conditions

Schizophrenia

Interventions

Iloperidone

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

Jun 2023

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

Jan 13, 2021Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Aug 30, 2022Actual

First Submitted Date

Jan 13, 2021

First Submission Date that Met QC Criteria

Jan 13, 2021

First Posted Date

Jan 15, 2021Actual

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

Jun 27, 2023

Last Update Posted Date

Jun 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a multicenter, open-label, adaptive, repeat-dose study to evaluate the safety, tolerability, and pharmacokinetics of iloperidone long-acting injection (LAI) in patients with schizophrenia.

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

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Iloperidone	Experimental		Drug: Iloperidone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iloperidone	Drug	oral tablet, long-acting injection	Iloperidone	VYV-683

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection.	As measured by plasma concentrations.	24 weeks
Assessment of safety and tolerability of repeat-dosing of iloperidone given as a long-acting injection.	As measured by spontaneous reporting of adverse events (AEs).	24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing and able to provide written informed consent.
Male or female patients 18 to 65 years of age (inclusive).
Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for at least 1 year.
Symptomatically stable within the past two months.

Exclusion Criteria:

Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
Pregnant or nursing (lactating) women.
A positive test for drugs of abuse.

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		Garden Grove	California	92845	United States
Vanda Investigational Site

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