Food Effect Study of VHX-896 in Healthy Volunteers

Phase 1CompletedNCT06803290

Vanda Pharmaceuticals24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

VHX-896DRUG

Oral tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Vanda Investigational Site

Springfield, Missouri, United States

Outcomes

Primary Outcomes

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

As measured by plasma concentrations

Time frame: 96 Hours

Secondary Outcomes

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.

Time frame: 17 Days

Data from ClinicalTrials.gov

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