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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04712734
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Iloperidone Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Iloperidone

Arm Intervention/treatment
Experimental: Iloperidone Drug: Iloperidone
oral tablet, long-acting injection
Other Name: VYV-683




Primary Outcome Measures :
  1. Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection. [ Time Frame: 24 weeks ]
    As measured by plasma concentrations.

  2. Assessment of safety and tolerability of repeat-dosing of iloperidone given as a long-acting injection. [ Time Frame: 24 weeks ]
    As measured by spontaneous reporting of adverse events (AEs).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712734


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

Locations
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United States, California
Vanda Investigational Site Recruiting
Garden Grove, California, United States, 92845
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
United States, Maryland
Vanda Investigational Site Recruiting
Gaithersburg, Maryland, United States, 20877
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
United States, New Jersey
Vanda Investigational Site Recruiting
Marlton, New Jersey, United States, 08053
Contact: Vanda Pharmaceuticals Inc.    202-734-3400      
Sponsors and Collaborators
Vanda Pharmaceuticals
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04712734    
Other Study ID Numbers: VP-VYV-683-1005
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Iloperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs