A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

Study Overview
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Brief Summary
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A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

Official Title
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A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder

Conditions
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Jet Lag Disorder

Intervention / Treatment
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* Drug: Tasimelteon
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability and acceptance to provide written consent Men or women between 18-75 years Body Mass Index of ≥ 18 and ≤ 30 kg/m2 Exclusion Criteria: History (within the 12 months prior to screening) of psychiatric disorders Major surgery, trauma, illness or immobile for 3 or more days within the past month Pregnancy or recent pregnancy (within 6 weeks) A positive test for drugs of abuse at the screening visit Any other sound medical reason as determined by the clinical investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tasimelteon<br>tasimelteon, administered as oral capsule(s) | Drug: Tasimelteon<br>* capsule<br>|
| Placebo Comparator: Placebo<br>Placebo, administered as oral capsule(s) | Drug: Placebo<br>* capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time in the First Two-Thirds of the Night on the Night(s) Most Likely to be Disrupted | Measured using polysomnography (PSG) and analyzed as change from baseline. Examination of the observational phase baseline data demonstrated that Night 3 was the night most disrupted. | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Severity (PGI-S) Day 4 | Self-reported global index measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The PGI-S is a single question asking the subject to rate their jet-lag condition at the present time on a scale of 1 Normal to 4 Severe. | 1 Day | 
| Total Sleep Time in the First Two-Thirds of the Night (All 3 Nights) | Measured using polysomnography (PSG) and analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. | 3 Days | 
| Subjective Total Sleep Time on Night 3 | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline | 1 Day | 
| Subjective Sleep Quality Night 3 | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline. Sleep quality was ranked from 1 Poor to 5 Excellent and was the subscale of the post-sleep questionnaire used to determine subjective sleep quality. | 1 Day | 
| Subjective Sleep Latency Night 3 | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline | 1 Day | 
| Subjective Wake After Sleep Onset Night 3 | Measured using the post-sleep questionnaire on Day 4 and analyzed as change from baseline | 1 Day | 
| Karolinska Sleepiness Scale Day 4 | Self-reported fatigue measure analyzed as change from baseline. The baseline was the corresponding measurement in the screening flight. The KSS is a single question asking the subject to rate how sleepy they feel at that moment on a 9-point scale where 1 = extremely awake and 9 = extremely sleepy/fighting to stay wake. | 1 Day |