Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects
NCT ID: NCT06323655
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2018-07-19
2018-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Tasimelteon
single dose
Tasimelteon
oral capsule
Active Control Placebo
oral capsule
Placebo
single dose
Active Control Placebo
oral capsule
Tasimelteon Placebo
oral capsule
Active Control
single dose
Tasimelteon Placebo
oral capsule
Active Control
oral capsule
Interventions
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Tasimelteon
oral capsule
Active Control Placebo
oral capsule
Tasimelteon Placebo
oral capsule
Active Control
oral capsule
Eligibility Criteria
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Inclusion Criteria
* Healthy subjects with no medical, psychiatric, or current sleep disorders;
* Men and women ages 21 - 55, inclusive;
* Possession of a valid driver's license ≥ 3 years with reported annual mileage ≥ 3,000 km.
Exclusion Criteria
* Subjects who are unable to read or speak English or French.
21 Years
55 Years
ALL
Yes
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigational Site
Laval, Quebec, Canada
Countries
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Other Identifiers
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VP-VEC-162-1201
Identifier Type: -
Identifier Source: org_study_id
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