VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
Status and phase
Completed
Phase 3
Conditions
Insomnia
Treatments
Drug: 100 mg VEC-162
Drug: Placebo
Drug: 20 mg VEC-162
Drug: 50 mg VEC-162
Details and patient eligibility
About
The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.
Enrollment
411 patients
Sex
All
Ages
21 to 50 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Healthy subjects with no medical, psychiatric or current sleep disorders.
- Subject must sign a written consent form.
Exclusion criteria
- Recent history of night shift work or jet lag.
- Prior experience sleeping in a sleep lab environment.
- History of sleep disorders.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
411 participants in 4 patient groups, including a placebo group
Placebo
Placebo Comparator group
Description:
Take orally 30 minutes prior to bedtime.
Treatment:
Drug: Placebo
20 mg VEC-162
Experimental group
Description:
20 mg taken orally 30 minutes prior to bedtime.
Treatment:
Drug: 20 mg VEC-162
50 mg VEC-162
Experimental group
Description:
50 mg taken orally 30 minutes prior to bedtime.
Treatment:
Drug: 50 mg VEC-162
100 mg VEC-162
Experimental group
Description:
100 mg taken orally 30 minutes prior to bedtime.
Treatment:
Drug: 100 mg VEC-162
Trial contacts and locations
19
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Data sourced from clinicaltrials.gov
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