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

NCT02776215 | Completed Phase 1

• 1 other identifier: VP-VEC-162-4201
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Pharmacokinetic Dosing

EXPERIMENTAL

Single-dose pharmacokinetics of tasimelteon

Drug: tasimelteon

Interventions

tasimelteon DRUG

Melatonin receptor agonist

Also known as: Hetlioz

Pharmacokinetic Dosing

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females 3 to \<18 years of age who are legally blind \[defined as having a visual acuity of 20/200 or less in the better-seeing eye with best conventional correction (glasses or contact lenses) and/or a visual field of 20 degrees or less in the better-seeing eye\], males or females 3 to \<18 years of age with SMS and with a nighttime sleep complaint and males or females 3 to \<18 years of age with ASD and with a nighttime sleep complaint;
• Weigh at least 10 kg;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (1)

Parexel Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Autism Spectrum Disorder; Smith-Magenis Syndrome

Interventions

tasimelteon

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Vanda Pharmaceuticals

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 18, 2016
• Study Start: October 4, 2016
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)