CompletedPhase 1

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

United States24 participantsStarted 2016-10-04

Plain-language summary

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

Who can participate

Age range3 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. 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;

What they're measuring

Area under the curver (AUC) of tasimelteon and its metabolites

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: Day 1

Safety and tolerability of tasimelteon as measured by Pediatric Adverse Event Reporting System (PAERS)

Trial details

NCT IDNCT02776215

SponsorVanda Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12-20

View on ClinicalTrials.gov More Circadian Rhythm Sleep Disorders trials

Who can participate

Age range3 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. 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;

What they're measuring

Area under the curver (AUC) of tasimelteon and its metabolites

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: Day 1

Safety and tolerability of tasimelteon as measured by Pediatric Adverse Event Reporting System (PAERS)