Back to resultsA Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Iloperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
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.
Sites / Locations
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Iloperidone
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection.
As measured by plasma concentrations.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04712734
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iloperidone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Iloperidone
Other Intervention Name(s)
VYV-683
Intervention Description
oral tablet, long-acting injection
Primary Outcome Measure Information:
Title
Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection.
Description
As measured by plasma concentrations.
Time Frame
24 weeks
Title
Assessment of safety and tolerability of repeat-dosing of iloperidone given as a long-acting injection.
Description
As measured by spontaneous reporting of adverse events (AEs).
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Vanda Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Vanda Investigational Site
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Vanda Investigational Site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia
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