Food Effect Study of VHX-896 in Healthy Volunteers | NCT06803290

Studies
Food Effect Study of VHX-896 in Healthy Volunteers

NCT06803290

Sponsor

Vanda Pharmaceuticals

Status

Completed

Last Update Posted

Jan 31, 2025Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy

Interventions

VHX-896

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 21, 2022Actual

Primary Completion Date

Dec 27, 2022Actual

Completion Date

Dec 27, 2022Actual

First Submitted Date

Jan 27, 2025

First Submission Date that Met QC Criteria

Jan 27, 2025

First Posted Date

Jan 31, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2025

Last Update Posted Date

Jan 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence A: fed then fasted	Experimental		Drug: VHX-896
Sequence B: fasted then fed	Experimental		Drug: VHX-896

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VHX-896	Drug	Oral tablet	Sequence A: fed then fasted Sequence B: fasted then fed

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanda Investigational Site		Springfield	Missouri	65802	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided