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

Circadian Rhythm Sleep Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490945
• Other study ID #: VP-VEC-162-2101
• Status: Completed
• Phase: Phase 2
• First received: June 22, 2007
• Last updated: August 8, 2014
• Start date: July 2004
• Est. completion date: March 2005

Study information

• Verified date: August 2014
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Circadian Rhythm Sleep Disorders
• Parasomnias
• Sleep Disorders
• Sleep Disorders, Circadian Rhythm

Intervention

Drug:
• VEC-162

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Boston	Massachusetts
United States	Vanda Investigational Site	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian Phase Shift	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.	Night 3 and Night 4	No
Primary	Mean Sleep Efficiency	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.	Night 4 and Night 2	No
Secondary	Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)	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.	Night 2 and Night 4	No
Secondary	VEC-162 AUC		Night 4	No
Secondary	VEC-162 Cmax		Night 4	No
Secondary	VEC-162 Tmax		Night 4	No