NCT06803290

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jun 2022

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 27, 2025

Last Update Submit

January 27, 2025

Conditions

Healthy

Keywords

VHX-896Food Effect

Outcome Measures

Primary Outcomes (1)

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

    As measured by plasma concentrations

    96 Hours

Secondary Outcomes (1)

  • Assessment of safety and tolerability of single dose of VHX-896 tablets

    17 Days

Study Arms (2)

Sequence A: fed then fasted

EXPERIMENTAL
Drug: VHX-896

Sequence B: fasted then fed

EXPERIMENTAL
Drug: VHX-896

Interventions

VHX-896DRUG

Oral tablet

Sequence A: fed then fastedSequence B: fasted then fed

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanda Investigational Site

Springfield, Missouri, 65802, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

June 21, 2022

Primary Completion

December 27, 2022

Study Completion

December 27, 2022

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)