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

NCT00490945 | Completed Phase 2 Results

• 1 other identifier: VP-VEC-162-2101
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Circadian Rhythm Sleep Disorders

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)

  Night 2 and Night 4

• VEC-162 AUC

  Night 4

• VEC-162 Cmax

  Night 4

• VEC-162 Tmax

  Night 4

Interventions

VEC-162 DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• No medical, psychiatric, or sleep disorders
• Ability to provide written informed consent

You may not qualify if:

• Lifetime history of night shift work
• Evidence of any sleep disorder
• Psychiatric or neurological disorders

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (2)

Vanda Investigational Site

Boston, Massachusetts, United States

Location

Vanda Investigational Site

Detroit, Michigan, United States

Location

Related Publications (1)

• Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman EB. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet. 2009 Feb 7;373(9662):482-91. doi: 10.1016/S0140-6736(08)61812-7. Epub 2008 Dec 4.

  PMID: 19054552 DERIVED

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Results Point of Contact

• Title: Marlene Dressman, Ph.D.
• Organization: Vanda Pharmaceuticals Inc.

marelene.dressman@vandapharma.com

202-734-3462

Study Officials

• Marlene Dressman, PhD

  Vanda Pharmaceuticals Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 25, 2007
• Study Start: July 1, 2004
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: August 26, 2014
• Results First Posted: August 26, 2014

Record last verified: 2014-08

Locations

US (2)