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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014