Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers

Vanda Pharmaceuticals45 enrolled

Overview

The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Circadian Rhythm Sleep Disorders

Interventions

VEC-162DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * No medical, psychiatric, or sleep disorders * Ability to provide written informed consent Exclusion Criteria: * Lifetime history of night shift work * Evidence of any sleep disorder * Psychiatric or neurological disorders

Locations (2)

Vanda Investigational Site

Boston, Massachusetts, United States

Vanda Investigational Site

Detroit, Michigan, United States

Outcomes

Primary Outcomes

Circadian Phase Shift

Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml.

Time frame: Night 3 and Night 4

Mean Sleep Efficiency

Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds.

Time frame: Night 4 and Night 2

Secondary Outcomes

Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)

Wake After Sleep Onset is defined as the total time that is scored as awake in a PSG occurring between sleep onset and lights-on prompt. Latency to Persistent Sleep is defined as the number of epochs (one 30-second interval of the sleep episode) from the beginning of the recording (lights-out) to the start of persistent sleep (first 20 consecutive non-wake state) divided by 2.

Time frame: Night 2 and Night 4

VEC-162 AUC

Time frame: Night 4

VEC-162 Cmax

Time frame: Night 4

VEC-162 Tmax

Time frame: Night 4

Data from ClinicalTrials.gov

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