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Completed

NCT Number: NCT06803290

Food Effect Study of VHX-896 in Healthy Volunteers

A single center, two-period, randomized study to evaluate the food effect of VHX-896 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.
  • No clinically significant medical, psychiatric or sleep disorders.

Exclusion criteria

  • Participants with history of drug or alcohol abuse in last 12 months.
  • Participants who suffered from significant physical illness in the 4-week period preceding baseline.
  • Pregnant or nursing (lactating) women.

Treatment and study plan

VHX-896

Drug

Oral tablet

Primary outcomes

  1. Comparative bioavailability of VHX-tablets under fed versus fasted conditions.

    Time frame: 96 Hours

    As measured by plasma concentrations

Secondary outcomes

  1. Assessment of safety and tolerability of single dose of VHX-896 tablets

    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, Two-Sequence, Two-Treatment Randomized, Single Oral Dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetic Profile of VHX-896 in Healthy Volunteers

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

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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