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

Sponsor
Vanda Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04712734
Collaborator
(none)
24
Enrollment
3
Locations
1
Arm
19.6
Anticipated Duration (Months)
8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 13, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Iloperidone

Drug: Iloperidone
oral tablet, long-acting injection
Other Names:
  • VYV-683

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection. [24 weeks]

      As measured by plasma concentrations.

    2. Assessment of safety and tolerability of repeat-dosing of iloperidone given as a long-acting injection. [24 weeks]

      As measured by spontaneous reporting of adverse events (AEs).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanda Investigational Site Garden Grove California United States 92845
    2 Vanda Investigational Site Gaithersburg Maryland United States 20877
    3 Vanda Investigational Site Marlton New Jersey United States 08053

    Sponsors and Collaborators

    • Vanda Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vanda Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04712734
    Other Study ID Numbers:
    • VP-VYV-683-1005
    First Posted:
    Jan 15, 2021
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Schizophrenia
    Iloperidone

    Study Results

    No Results Posted as of Jun 3, 2022