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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490945
Recruitment Status : Completed
First Posted : June 25, 2007
Results First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Information provided by:
Vanda Pharmaceuticals

June 22, 2007
June 25, 2007
February 28, 2014
August 26, 2014
August 26, 2014
July 2004
March 2005   (Final data collection date for primary outcome measure)
  • Circadian Phase Shift [ Time Frame: Night 3 and Night 4 ]
    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 [ Time Frame: Night 4 and Night 2 ]
    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.
Exposure response to VEC-162 on induction of circadian phase shift and sleep efficiency parameters
Complete list of historical versions of study NCT00490945 on Archive Site
  • Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS) [ Time Frame: Night 2 and Night 4 ]

    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 [ Time Frame: Night 4 ]
  • VEC-162 Cmax [ Time Frame: Night 4 ]
  • VEC-162 Tmax [ Time Frame: Night 4 ]
  • Amount of time spent asleep, number of awake at night, and sleep quality
  • Safety and tolerability of VEC-162
Not Provided
Not Provided
Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers
A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of VEC-162 on Circadian Rhythm in Healthy Subjects
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Circadian Rhythm Sleep Disorders
Drug: VEC-162
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2005
March 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Vanda Pharmaceuticals
Not Provided
Study Director: Marlene Dressman, PhD Vanda Pharmaceuticals Inc
Vanda Pharmaceuticals
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP