Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions
Schizophrenia
Interventions
DRUG

Brexpiprazole (OPC-34712)

Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.

Trial Locations (10)

20016

Washington D.C.

30331

Atlanta

44106

Cleveland

45219

Cincinnati

72211

Little Rock

77381

The Woodlands

84058

Orem

90230

Culver City

92858

Orange

08053

Marlton

All Listed Sponsors
collaborator

H. Lundbeck A/S

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT02411695 - Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia | Biotech Hunter | Biotech Hunter