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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712734
• Other study ID #: VP-VYV-683-1005
• Status: Completed
• Phase: Phase 1
• Start date: January 13, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: June 2023
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Iloperidone
oral tablet, long-acting injection

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Gaithersburg	Maryland
United States	Vanda Investigational Site	Garden Grove	California
United States	Vanda Investigational Site	Marlton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection.	As measured by plasma concentrations.	24 weeks
Primary	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