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

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ClinicalTrials.gov Identifier: NCT00490945
Recruitment Status : Completed
First Posted : June 25, 2007
Results First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Sponsor:
Information provided by:
Vanda Pharmaceuticals

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Circadian Rhythm Sleep Disorders Drug: VEC-162 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : July 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Circadian Phase Shift [ Time Frame: Night 3 and Night 4 ]
    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.

  2. Mean Sleep Efficiency [ Time Frame: Night 4 and Night 2 ]
    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 :
  1. Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS) [ Time Frame: Night 2 and Night 4 ]

    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.


  2. VEC-162 AUC [ Time Frame: Night 4 ]
  3. VEC-162 Cmax [ Time Frame: Night 4 ]
  4. VEC-162 Tmax [ Time Frame: Night 4 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490945


Locations
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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
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Study Director: Marlene Dressman, PhD Vanda Pharmaceuticals Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00490945    
Other Study ID Numbers: VP-VEC-162-2101
First Posted: June 25, 2007    Key Record Dates
Results First Posted: August 26, 2014
Last Update Posted: August 26, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
 Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases