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
|Condition or disease||Intervention/treatment||Phase|
|Circadian Rhythm Sleep Disorders||Drug: VEC-162||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|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|
- 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.
- 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.
- 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.
- VEC-162 AUC [ Time Frame: Night 4 ]
- VEC-162 Cmax [ Time Frame: Night 4 ]
- VEC-162 Tmax [ Time Frame: Night 4 ]
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
|United States, Massachusetts|
|Vanda Investigational Site|
|Boston, Massachusetts, United States|
|United States, Michigan|
|Vanda Investigational Site|
|Detroit, Michigan, United States|
|Study Director:||Marlene Dressman, PhD||Vanda Pharmaceuticals Inc|