Food Effect Study of VHX-896 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: VHX-896

• Registration Number: NCT06803290
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-21
• Primary Completion: 2022-12-27
• Study Completion: 2022-12-27
• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A: fed then fasted	VHX-896	-
Sequence B: fasted then fed	VHX-896	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Springfield, Missouri, United States