VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia

Vanda Pharmaceuticals411 enrolled

Overview

The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

411

Conditions

Insomnia

Interventions

20 mg VEC-162DRUG

20 mg VEC-162

50 mg VEC-162DRUG

50 mg VEC-162

100 mg VEC-162DRUG

100 mg VEC-162

Placebo

Eligibility

Sex: ALLMin age: 21 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects with no medical, psychiatric or current sleep disorders. * Subject must sign a written consent form. Exclusion Criteria: * Recent history of night shift work or jet lag. * Prior experience sleeping in a sleep lab environment. * History of sleep disorders.

Locations (19)

Vanda Investigational Site

Birmingham, Alabama, United States

Vanda Investigational Site

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Average Improvement of Latency to Persistent Sleep (LPS)

The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.

Time frame: Night 1

Secondary Outcomes

Average Improvement of Wake After Sleep Onset (WASO)

The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.

Time frame: Night 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.