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Completed

NCT Number: NCT04969211

Bioequivalence Study Between VHX-896 Tablets and 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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanda Investigational Site

Springfield, Missouri, 65802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VHX-896 and iloperidone

Drug

oral tablet

Iloperidone and VHX-896

Drug

oral tablet

Primary outcomes

  1. Bioequivalence between VHX-896 tablets relative to iloperidone tablets

    Time frame: 96 hours

    as measured by plasma concentrations

  2. 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

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2021
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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