NCT04712734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Jan 2021

Typical duration for phase_1 schizophrenia

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

January 13, 2021

Last Update Submit

June 27, 2023

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Iloperidone

EXPERIMENTAL
Drug: Iloperidone

Interventions

IloperidoneDRUG

oral tablet, long-acting injection

Also known as: VYV-683
Iloperidone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vanda Investigational Site

Garden Grove, California, 92845, United States

Location

Vanda Investigational Site

Gaithersburg, Maryland, 20877, United States

Location

Vanda Investigational Site

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

iloperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

January 13, 2021

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

June 29, 2023

Record last verified: 2023-06

Locations

US(3)