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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06803290

Enrollment

Registered

2025-01-31

Start date

2022-06-21

Completion date

2022-12-27

Last updated

2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

VHX-896, Food Effect

Brief summary

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

Interventions

DRUGVHX-896

Oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Assessment of safety and tolerability of single dose of VHX-896 tablets	17 Days	As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026