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

Primary Purpose

Circadian Rhythm Sleep Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VEC-162
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Circadian Rhythm Sleep Disorders

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanda Investigational Site
  • Vanda Investigational Site

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
VEC-162 AUC
VEC-162 Cmax
VEC-162 Tmax

Full Information

First Posted
June 22, 2007
Last Updated
August 8, 2014
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00490945
Brief Title
Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers
Official Title
A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of VEC-162 on Circadian Rhythm in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circadian Rhythm Sleep Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
VEC-162
Primary Outcome Measure Information:
Title
Circadian Phase Shift
Description
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
Title
Mean Sleep Efficiency
Description
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 Outcome Measure Information:
Title
Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)
Description
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
Title
VEC-162 AUC
Time Frame
Night 4
Title
VEC-162 Cmax
Time Frame
Night 4
Title
VEC-162 Tmax
Time Frame
Night 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene Dressman, PhD
Organizational Affiliation
Vanda Pharmaceuticals Inc
Official's Role
Study Director
Facility Information:
Facility Name
Vanda Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Vanda Investigational Site
City
Detroit
State/Province
Michigan
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19054552
Citation
Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman EB. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet. 2009 Feb 7;373(9662):482-91. doi: 10.1016/S0140-6736(08)61812-7. Epub 2008 Dec 4. Erratum In: Lancet. 2009 Apr 11;373(9671):1252.
Results Reference
derived

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

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