Marlton, New Jersey 08053

  • Schizophrenia

Purpose:

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.


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.


Study is Available At:


Original ID:

VP-VYV-683-1005


NCT ID:

NCT04712734


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

An Open-label, Adaptive, Repeat-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Iloperidone Long-acting Injection (LAI) in Patients With Schizophrenia


Overall Status:

Recruiting


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanda Pharmaceuticals


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Vanda Pharmaceuticals Inc.
202-734-3400
VYV683@vandapharma.com

Study Dates

Start Date:January 13, 2021
Completion Date:January 2022
Completion Type:Anticipated
Primary Completion Date:January 2022
Primary Completion Type:Anticipated
Verification Date:April 2021
Last Changed Date:April 1, 2021
First Received Date:January 13, 2021

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:Iloperidone
Description:oral tablet, long-acting injection
Arm Name:Iloperidone
Other Name:VYV-683

Study Arms

Study Arm Type:Experimental
Arm Name:Iloperidone

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Vanda Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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