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
  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:
  • 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.


Secondary Outcome Measures:
  • 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 ]

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
Results First Received: February 28, 2014
Last Updated: August 8, 2014
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 September 15, 2014