Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents

Study Overview
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Brief Summary
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Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.

Official Title
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Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents

Conditions
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Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder, Autism Spectrum Disorder, Smith-Magenis Syndrome

Intervention / Treatment
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* Drug: tasimelteon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females who are legally blind [defined as having a visual acuity of 20/200 or less in the better-seeing eye with best conventional correction (glasses or contact lenses) and/or a visual field of 20 degrees or less in the better-seeing eye], 3 to <18 years of age or males and females with SMS and 3 to <16 years of age with a nighttime sleep complaint and 3 to <18 years of age or males and females with ASD and 3 to <18 years of age with a nighttime sleep complaint; Weigh at least 16 kg; 3 Diagnosis of SMS determined by a prior positive genetic test result as indicated by parent/guardian; Diagnosis of ASD as indicated by parent/guardian; or a diagnosis of Non-24 as determined by DSM-5 diagnostic criteria for the Circadian rhythm sleep-wake disorder, Non-24-hour sleep-wake hour type: A persistent or recurrent pattern of sleep disruption that is primarily due to an alteration of the circadian system or to a misalignment between the endogenous circadian rhythm and the sleep-wake schedule required by an individual's physical environment or social or professional schedule; The sleep disruption leads to excessive sleepiness or insomnia, or both; The sleep disturbance causes clinically significant distress or impairment in social, occupational, and other important areas of functioning. Exclusion Criteria: For blind subjects only: Subjects who have a probable diagnosis of a current sleep disorder other than Non-24-Hour Sleep-Wake Disorder that is the primary cause of the sleep disturbance based on clinical investigator medical judgment; For blind subjects only: History (within the 12 months prior to screening) of psychiatric disorders including ADHD, Neurodisabilities, Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder, that is not being successfully treated or has not been resolved and that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures; History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacokinetic Dosing<br>Single-dose pharmacokinetics of tasimelteon | Drug: tasimelteon<br>* Melatonin receptor agonist<br>* Other names: Hetlioz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curver (AUC) of tasimelteon and its metabolites |  | Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose | 
| Maximum concetration (Cmax) of tasimelteon and its metabolites |  | Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose | 
| Steady-state concentration (Css) of tasimelteon and its metabolites |  | Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose | 
| Half-life of tasimelteon and its metabolites |  | Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose | 
| Trough concentration (Ctrough) of tasimelteon and its metabolites |  | Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose | 
| Safety and tolerability of tasimelteon as measured by spontaneous reporting of adverse events (AEs) |  | Day 1 | 
| Safety and tolerability of tasimelteon as measured by Pediatric Adverse Event Reporting System (PAERS) |  | Day 1 |