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Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia

Sponsor
Vanda Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04127058
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
1.7
Actual Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-center open-label study to be conducted in the United States in subjects with bipolar I disorder or schizophrenia.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Safety/Tolerance Study to Evaluate a New Titration Scheme in Patients With Bipolar I Disorder or Schizophrenia
Actual Study Start Date :
Oct 7, 2019
Actual Primary Completion Date :
Nov 27, 2019
Actual Study Completion Date :
Nov 27, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: CYP2D6 non-poor metabolizers

titrated up to 24 mg daily (12 mg b.i.d.)

Drug: Iloperidone
Oral Tablet
Other Names:
  • FANAPT®
  • VYV-683

    		•
    Other: CYP2D6 poor metabolizers

    titrated up to 12 mg daily (6 mg b.i.d.)

    Drug: Iloperidone
    Oral Tablet
    Other Names:
  • FANAPT®
  • VYV-683

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The frequency of treatment-emergent adverse events as measured by the number of events [7 days]

    Eligibility Criteria

    Criteria

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

    • Male or female patients 18 to 65 years of age (inclusive)

    • Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type as per DSM-V criteria

    • Symptomatically stable within the past two months

    Exclusion Criteria:

    • Exposure to any investigational medication, including placebo, in the past 60 days

    • Non-response to clozapine

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanda Investigational Site Marlton New Jersey United States 08009

    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:
    NCT04127058
    Other Study ID Numbers:
    • VP-VYV-683-1004
    First Posted:
    Oct 15, 2019
    Last Update Posted:
    Apr 13, 2020
    Last Verified:
    Apr 1, 2020
    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 Apr 13, 2020