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Clinical trial

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Three-way Crossover Study in Healthy Subjects to Evaluate the Next-day Residual Effects of 20 mg Tasimelteon

ID
Name
VP-VEC-162-1201
Description
The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects.
Trial arms
Trial start
2018-07-19
Estimated PCD
2018-08-28
Trial end
2018-08-28
Status
Completed
Phase
Early phase I
Treatment
Tasimelteon
oral capsule
Arms:
Tasimelteon
Active Control Placebo
oral capsule
Arms:
Placebo, Tasimelteon
Tasimelteon Placebo
oral capsule
Arms:
Active Control, Placebo
Active Control
oral capsule
Arms:
Active Control
Size
48
Primary endpoint
Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP)
Day 1 of Treatment Period 1, Treatment Period 2, and Treatment Period 3 (each Period is 1 day, separated by washout)
Eligibility criteria
Inclusion Criteria: * Ability to provide written consent; * 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: * Pregnancy or recent pregnancy; * Subjects who are unable to read or speak English or French.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}
Updated at
2024-03-21

1 organization

3 products

1 indication

Organization
Vanda Pharmaceuticals
Product
Tasimelteon
Indication
Healthy Control Participants
Product
Active Control Placebo
Product
Active Control