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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Circadian Rhythm Sleep Disorders
 Drug: VEC-162
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Effects of VEC-162 on Circadian Rhythm in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Further study details as provided by Vanda Pharmaceuticals:

Primary Outcome Measures:
  • Exposure response to VEC-162 on induction of circadian phase shift and sleep efficiency parameters

Secondary Outcome Measures:
  • Amount of time spent asleep, number of awake at night, and sleep quality
  • Safety and tolerability of VEC-162

Enrollment: 45
Study Start Date: July 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490945

Locations
United States, Massachusetts
Vanda Investigational Site
Boston, Massachusetts, United States
United States, Michigan
Vanda Investigational Site
Detroit, Michigan, United States
Sponsors and Collaborators
Vanda Pharmaceuticals
Investigators
Study Director: Marlene Dressman, PhD Vanda Pharmaceuticals Inc
  More Information

No publications provided by Vanda Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00490945     History of Changes
Other Study ID Numbers: VP-VEC-162-2101
Study First Received: June 22, 2007
Last Updated: February 26, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
 Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases

ClinicalTrials.gov processed this record on June 17, 2013