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

• ClinicalTrials.gov Identifier: NCT02776215
• Recruitment Status: Unknown
• First Posted: May 18, 2016
• Last Update Posted: March 1, 2017
• Sponsor: Vanda Pharmaceuticals
• Information provided by (Responsible Party): Vanda Pharmaceuticals

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 (Clinical Trial)
• Estimated 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: September 2016
• Estimated Primary Completion Date: December 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pharmacokinetic Dosing; Single-dose pharmacokinetics of tasimelteon	Drug: tasimelteon; Melatonin receptor agonist; Other Name: Hetlioz

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. 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;
2. 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:

1. 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;
2. The sleep disruption leads to excessive sleepiness or insomnia, or both;
3. The sleep disturbance causes clinically significant distress or impairment in social, occupational, and other important areas of functioning.

Exclusion Criteria:

1. 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;
2. 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;
3. History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;

Contacts and Locations

Contacts

Contact: Vanda Pharmaceuticals; 202-734-3400

Locations

United States, Maryland

Parexel Early Phase Clinical Unit; Recruiting

Baltimore, Maryland, United States, 21225

Contact: Amy Roach 667-210-5356 Amy.Roach@parexel.com

Principal Investigator: Shannon Marriot

Sponsors and Collaborators

Vanda Pharmaceuticals

Investigators

• Study Director: Vanda Pharmaceuticals; Sponsor GmbH

More Information

• Responsible Party: Vanda Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02776215
• Other Study ID Numbers: VP-VEC-162-4201
• First Posted: May 18, 2016
• Last Update Posted: March 1, 2017
• Last Verified: January 2017

Additional relevant MeSH terms:

Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Smith-Magenis Syndrome; Disease; Autism Spectrum Disorder; Pathologic Processes; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Chronobiology Disorders; Dyssomnias; Occupational Diseases; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn