Clinical Trial: Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Vanda Pharmaceuticals

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Vanda Pharmaceuticals

Dates:
Date Received: May 16, 2016
Date Started: September 2016
Date Completion:
Last Updated: February 27, 2017
Last Verified: January 2017