Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia

Study Overview
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Brief Summary
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The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.

Official Title
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Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia

Conditions
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Jet Lag Type Insomnia

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, fluent in English; Healthy subjects with no medical, psychiatric or current sleep disorders; Men or women between 18-75 years; Body Mass Index of ≥ 18 and ≤ 30 kg/m2. Exclusion Criteria: 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 or evaluation visit.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tasimelteon<br> | Drug: Tasimelteon<br>* Oral capsule<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral 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 | Total sleep time during the first 2/3 of the night following an 8-hour phase advance bedtime, as measured by PSG. This is representative of trans meridian travel across 8 time zones. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | Total Sleep Time as measured by PSG. | 1 Day | 
| Latency to Persistent Sleep | Length of time elapsed between lights out and onset of persistent sleep as measure by PSG. | 1 Day | 
| Wake After Sleep Onset | The amount of wake time during the sleep period after sleep onset (as measured by polysomnography). | 1 Day | 
| Next Day Alertness as Measured by the Karolinska Sleepiness Scale (Night 1 Average Score) | A 9-point scale that measures subjective levels of fatigue by asking how sleepy subjects feel at that moment: 1 = extremely awake to 9 =extremely sleepy/fighting to stay awake. | 1 Day | 
| Next Day Alertness as Measured by the Visual Analogue Scale (Night 1 Average Score) | The VAS was a self-rated scale to assess sleepiness. Participants marked along a 100 mm line to represent their current state of sleepiness, 0 being very sleepy and 100 being very alert. The VAS was administered four times following the dose administration after awakening. | 1 Day |