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

Sponsor

Vanda Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02776215

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Circadian Rhythm Sleep Disorders Non-24 Hour Sleep-Wake Disorder Autism Spectrum Disorder Smith-Magenis Syndrome	Drug: tasimelteon	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pharmacokinetic Dosing Single-dose pharmacokinetics of tasimelteon	Drug: tasimelteon Melatonin receptor agonist Other Names: Hetlioz

Arm

Intervention/Treatment

Experimental: Pharmacokinetic Dosing

Single-dose pharmacokinetics of tasimelteon

Drug: tasimelteon

Melatonin receptor agonist

Other Names:

Hetlioz

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parexel Early Phase Clinical Unit	Baltimore	Maryland	United States	21225

Sponsors and Collaborators

Vanda Pharmaceuticals

Investigators

Study Director: Vanda Pharmaceuticals, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vanda Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT02776215

Other Study ID Numbers:

VP-VEC-162-4201

First Posted:

May 18, 2016

Last Update Posted:

Mar 1, 2017

Last Verified:

Jan 1, 2017

Additional relevant MeSH terms:

Sleep Wake Disorders

Sleep Disorders, Circadian Rhythm

Smith-Magenis Syndrome

Disease

Autism Spectrum Disorder

Study Results

No Results Posted as of Mar 1, 2017