Clinical trial NCT03373201
Conditions: Jet Lag Type Insomnia
Sponsor: Vanda Pharmaceuticals
Start date: 2017-10-16; Completion date: 2018-03-05
Enrollment: 320 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tasimelteon intervention 2: Placebo
Intervention descriptions: intervention 1: Oral capsule intervention 2: Oral capsule

Protocol documents:
Prot_SAP_001.pdf: 


3 
VP-VEC-162-3107 
February 23, 2018 
CONFIDENTIAL 
This material is the property of Vanda Pharmaceuticals Inc.  Do not disclose or use except as authorized in writing by the study sponsor. 
Name of Sponsor/Company: 
Vanda Pharmaceuticals Inc. 
Name of Investigational Product: 
Tasimelteon/VEC-162 
Name of Active Ingredient: 
Tasimelteon/VEC-162 
Title of Study: 
The JET8 study: a double-blind, placebo-controlled study to investigate tasimelteon in 
healthy subjects with jet-lag type insomnia induced by an 8-hour phase advance. 
Study center(s): Multicenter (USA) 
Studied period: 
Estimated date first subject enrolled: October 2017 
Estimated last subject enrolled: December 2017    
Phase of development: 
Phase III 
Number of subjects (planned): Up to 300 eligible subjects will be randomized and 
assigned to 20 mg tasimelteon or placebo in a 1:1 ratio. Treatment assignments will be 
made according to a randomization schedule. 
Diagnosis and main criteria for inclusion/exclusion: 
Healthy males or females 18-75 years of age, inclusive, who meet inclusion criteria. 
Investigational product, dosage and mode of administration: 
Tasimelteon will be administered orally as a dose of 20 mg. Tasimelteon dosage form 
will be size 1, dark blue, opaque, hard gelatin capsules with two white bars on the 
capsule body and cap, and filled with white to off-white powder. 
Duration of treatment: 
1 day/1 night 
Reference therapy, dosage and mode of administration: 
Placebo capsules will be provided in size and appearance identical to those containing 
tasimelteon and will be administered orally 


4 
VP-VEC-162-3107 
February 23, 2018 
CONFIDENTIAL 
This material is the property of Vanda Pharmaceuticals Inc.  Do not disclose or use except as authorized in writing by the study sponsor. 
 
 
Objectives: 
Primary Objectives: 
1. To assess the effects of tasimelteon 20 mg on nighttime sleep parameters as 
measured by Polysomnography (PSG) after an 8-hour phase advanced bedtime 
representative of transmeridian travel across 8 time zones. 
Secondary Objectives: 
1. To assess the effects of tasimelteon 20 mg on nighttime objective sleep 
parameters. 
2. To assess the effects of tasimelteon 20 mg on nighttime and daytime subjective 
parameters. 
3. To assess the safety and tolerability of single oral doses of tasimelteon 20 mg. 
Overall Design: 
This is a multicenter, randomized, double-blind, placebo-controlled, parallel pivotal 
trial to investigate the efficacy and safety of a single 20 mg oral dose of tasimelteon and 
matching placebo in healthy male and female subjects with jet lag type insomnia from 
an 8-hour phase advance. 
 
 


5 
VP-VEC-162-3107 
February 23, 2018 
CONFIDENTIAL 
This material is the property of Vanda Pharmaceuticals Inc.  Do not disclose or use except as authorized in writing by the study sponsor. 
 
 
This study will be divided into 2 phases: the screening phase and the 
randomization/evaluation phase. The screening phase consists of the screening visit, 
during which inclusion/exclusion criteria will be assessed and the baseline evaluations 
will be conducted. The randomization phase consists of a 1-day/1-night double-blind 
evaluation period in which the subject’s bedtime is advanced 8 hours. The screening 
visit and day/night in sleep clinic will be separated by at least 1 week. Subjects meeting 
all entry criteria for the study will enter the randomization phase. Eligible subjects will 
be admitted to a sleep clinic for one day and night of evaluation. Bedtime will be 
determined by their habitual bedtime (as determined from screening) in the originating 
time zone. For example, if a subject has a habitual bedtime of 22:00 they will be put to 
bed at 14:00, or 22:00 in the new “time zone.” A PSG will be performed throughout the 
night beginning prior to bedtime in the “new time zone.” Following the 8-hour phase 
advanced sleep, subjects will complete post-sleep questionnaire, KSS and VAS 
assessments. During this time subjects will also be provided with breakfast and lunch. 
After completing all required study procedures, the subjects be discharged from the 
study clinic. Throughout the study the subject’s sleep pattern will be monitored with an 
actiwatch and through subject reported sleep diaries. 
Statistical Methods: 
 
Nighttime sleep will be assessed by analysis of variance, with treatment group, clinical 
site, as main effect. A comparison will be made between the subjects treated with 
tasimelteon 20 mg and placebo. The primary efficacy analysis will be based on the ITT 
population. 
The statistical analyses will be detailed in the Statistical Analysis Plan.