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OpenTrials
Completed

NCT Number: NCT00490945

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

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.

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Key information

Conditions

Circadian Rhythm Sleep Disorders Chronobiology Disorders Dyssomnias Mental Disorders Nervous System Diseases Occupational Diseases Sleep Disorders, Circadian Rhythm Sleep Wake Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanda Investigational Site, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VEC-162

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of VEC-162 on Circadian Rhythm in Healthy Subjects

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 25, 2007
Registry last updated
Aug 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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