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

NCT02195167 Phase 1 COMPLETED

Pediatric PK study of SEP-225289 (Dasotraline)

Details

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	105
Start date	2014-07
Completion	2015-03

Conditions

• Pediatric Attention Deficit Hyperactivity Disorder

Interventions

• Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily

Primary outcomes

• Maximum concentration (Cmax), tmax, t1/2, area under the concentration from time zero to infinite time (AUC0-inf), and AUC0-last. — 0-51 Days
• Incidence of AEs, SAEs, and discontinuation due to AE — 0-51 Days
• Clinical Global Impressions-Severity of Illness (CGI-S) score and Columbia Suicide Severity Rating Scale (C-SSRS) evaluation. — 0-51 Days
• Absolute values-changes from baseline in clinical laboratory tests, vital signs, orthostatic changes, and 12-lead electrocardiograms (ECGs). — 0-51 Days

Countries

United States