Phase 2
N=39
Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers
Circadian Rhythm Sleep Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00490945 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Circadian Phase Shift — -0.48; 0.18; -1.14; -0.50 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VEC-162 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanda Pharmaceuticals
- Primary completion
- Mar 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Circadian Phase Shift |
-0.48; 0.18; -1.14; -0.50; -2.74 | — |
| PRIMARY Mean Sleep Efficiency |
-20.27; -7.77; -6.68; -5.87; -2.02; -12.30 | — |
| SECONDARY Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS) |
15.13; -8.25; 5.00; -3.71; -4.17; 77.00 | — |
| SECONDARY VEC-162 AUC |
171.73; 482.00; 614.34; 1916.06 | — |
| SECONDARY VEC-162 Cmax |
59.10; 139.94; 166.01; 417.80 | — |
| SECONDARY VEC-162 Tmax |
1.90; 2.04; 2.42; 3.03 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00490945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.