Dasotraline SEP360-105 Pediatric PK/PD Study

Pediatric Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Evaluation of Single Oral Doses of SEP-225289 in Subjects 6 to 17 Years of Age With Attention Deficit Hyperactivity Disorder

Status Completed

Clinical Trial Summary

Pediatric PK study of SEP-225289 (Dasotraline)

Clinical Trial Description

To characterize the pharmacokinetics (PK) and assess safety and tolerability of a range of single oral doses of SEP-225289 in subjects 6 to 17 years old with ADHD ;

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis
• Pediatric Attention Deficit Hyperactivity Disorder

• NCT number: NCT02195167
• Study type: Interventional
• Source: Sunovion
• Status: Completed
• Phase: Phase 1
• Start date: July 2014
• Completion date: March 2015