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

This study has been completed.
Sponsor:
Information provided by:
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00490945
First received: June 22, 2007
Last updated: August 8, 2014
Last verified: August 2014

June 22, 2007
August 8, 2014
July 2004
March 2005   (final data collection date for primary outcome measure)
  • Circadian Phase Shift [ Time Frame: Night 3 and Night 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ClinicalTrials.gov Archive Site
  • Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS) [ Time Frame: Night 2 and Night 4 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • VEC-162 Cmax [ Time Frame: Night 4 ] [ Designated as safety issue: No ]
  • VEC-162 Tmax [ Time Frame: Night 4 ] [ Designated as safety issue: No ]
  • 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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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. Epub 2008 Dec 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00490945
VP-VEC-162-2101
No
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