Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy Volunteers

July 8, 2022 updated by: Vanda Pharmaceuticals

An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers

This is a single center, two-period, randomized study to evaluate the Bioequivalence of VHX-896 Tablets Relative to Iloperidone Tablets in Healthy Volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Springfield, Missouri, United States, 65802
        • Vanda Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and/or female participants between 18 to 55 years (inclusive).
  • Have a Body Mass Index (BMI) of > 18.0 and < 30.0 kg/m2; (BMI = weight (kg)/ [height (m)]2).
  • Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.
  • Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.

Exclusion Criteria:

  • Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
  • Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded.
  • Pregnant or nursing (lactating) women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sequence A: VHX-896 then iloperidone
Drug: VHX-896 and iloperidone
oral tablet
EXPERIMENTAL: Sequence B: Iloperidone then VHX-896
Drug: Iloperidone and VHX-896
oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioequivalence between VHX-896 tablets relative to iloperidone tablets
Time Frame: 96 hours
as measured by plasma concentrations
96 hours
Assessment of Safety and Tolerability of a single dose of VHX-896
Time Frame: 17 days
As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs
17 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2021

Primary Completion (ACTUAL)

October 13, 2021

Study Completion (ACTUAL)

October 13, 2021

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 9, 2021

First Posted (ACTUAL)

July 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 8, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VHX-896-1101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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