Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.
This study is an open-label, single dose, non-controlled study to evaluate the PK and safety of tasimelteon in children and adolescents from 3 years to less than 18 years of age who were legally blind and met the diagnostic criteria for CRSWD Non-24 per DSM-V or who were diagnosed with a Neurodevelopmental Disorder (like ASD and SMS) and had a nighttime sleep complaint.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Melatonin receptor agonist
Parexel Early Phase Clinical Unit
Baltimore, Maryland, United States
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
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
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
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
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
Safety and tolerability of tasimelteon as measured by spontaneous reporting of adverse events (AEs)
Time frame: Day 1
Safety and tolerability of tasimelteon as measured by Pediatric Adverse Event Reporting System (PAERS)
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.