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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Circadian Rhythm Sleep Disorders

Treatments: Drug: VEC-162

Study type: Interventional

Funder types: Industry

Identifiers

NCT00490945

VP-VEC-162-2101

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind