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Food Effect Study of VHX-896 in Healthy Volunteers

NCT ID: NCT06803290

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-21

Study Completion Date

2022-12-27

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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VHX-896 Food Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A: fed then fasted

Group Type EXPERIMENTAL

VHX-896

Intervention Type DRUG

Oral tablet

Sequence B: fasted then fed

Group Type EXPERIMENTAL

VHX-896

Intervention Type DRUG

Oral tablet

Interventions

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VHX-896

Oral tablet

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanda Investigational Site

Springfield, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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VP-VHX-896-1102

Identifier Type: -

Identifier Source: org_study_id