NCT02195167

Dasotraline SEP360-105 Pediatric PK/PD Study

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Pediatric PK study of SEP-225289 (Dasotraline)

Detailed 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

Conditions

• Pediatric Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily	Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily. The planned dose for the first cohort is 1mg. There will be no more than a 2-fold increase in dose increase in dose between consecutive dose cohorts up to 8 mg, and dose cohorts beyond the 8 mg level will increment no more than 4mg. The maximum dose will not exceed 32mg." The language should precede the text that is currently there

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-07-21
• Last updated: 2015-03-31

Locations

12 sites across 1 country: United States