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: February 26, 2008
Last verified: February 2008

June 22, 2007
February 26, 2008
July 2004
March 2005   (final data collection date for primary outcome measure)
Exposure response to VEC-162 on induction of circadian phase shift and sleep efficiency parameters
Same as current
Complete list of historical versions of study NCT00490945 on ClinicalTrials.gov Archive Site
  • Amount of time spent asleep, number of awake at night, and sleep quality
  • Safety and tolerability of VEC-162
Same as current
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
February 2008

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