Food Effect Study of VHX-896 in Healthy Volunteers

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

A single center, two-period, randomized study to evaluate the food effect of VHX-896 tablets in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: VHX-896

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A: fed then fasted	Drug: VHX-896; Oral tablet
Experimental: Sequence B: fasted then fed	Drug: VHX-896; Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative bioavailability of VHX-tablets under fed versus fasted conditions.	As measured by plasma concentrations	96 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of safety and tolerability of single dose of VHX-896 tablets	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

• Sponsor: Vanda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): December 27, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Food Effect; VHX-896
• Other Study ID Numbers: VP-VHX-896-1102

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
• product manufactured in and exported from the U.S.: No