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

NCT02411695 | Completed Phase 1

• 1 other identifier: 331-10-233
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric Disorders.

Conditions

Schizophrenia

Keywords

Adolescent; Otsuka,; Brexpiprazole

Outcome Measures

Primary Outcomes (14)

• Reported Adverse Events (AEs) at 30 day Follow-Up

  30 day Follow-Up

• Change from Baseline to Day 17 in Vital Signs

  Baseline to Day 17

• Change from Baseline to Day 17 ECGs

  Baseline to Day 17

• Change from Baseline to Day 17 Hematology

  Baseline to Day 17

• Change from Baseline to Day 14 Physical examination

  Baseline to Day 14

• Change from Baseline to Day 17 Body weight

  Baseline to Day 17

• Change from Baseline to Day 17 Serum chemistry

  Including Prolactin concentrations

  Baseline to Day 17

• Change from Baseline to Day 17 Urinalysis

  Baseline to Day 17

• Maximal peak steady-state plasma concentration

  At Day 14

• Minimum trough steady-state plasma concentration

  At Day 14

• Time to maximum peak steady-state plasma concentration

  At Day 14

• Area under the concentration-time curve during the dosing interval at steady-state

  At Day 14

• Terminal elimination half-life

  At Day 14

• For Brex only, apparent cleanse and apparent volume of distribution

  At Day 14

Secondary Outcomes (11)

• Mean change in CGI-S score

  Day -1 of Dose Titration Phase to Day 7 and Day 14 of Fixed Dose Phase

• Mean change in CGI-I score

  Day 7 and Day 14

• Glycosylated haemoglobin [HbA1c]

  Baseline to Day 17

• Change from Baseline to Day 17 Adrenocorticotropic hormone [ACTH]

  Baseline to Day 17

• Change from Baseline to Day 17 Cortisol

  Baseline to Day 17

Study Arms (5)

Cohort 1

EXPERIMENTAL

0.5 mg, Brexpipraxzole (OPC-34712)

Drug: Brexpiprazole (OPC-34712)

Cohort 2

EXPERIMENTAL

1mg, Brexpipraxzole (OPC-34712)

Drug: Brexpiprazole (OPC-34712)

Cohort 3

EXPERIMENTAL

2mg, Brexpipraxzole (OPC-34712)

Drug: Brexpiprazole (OPC-34712)

Cohort 4

EXPERIMENTAL

3 mg, Brexpipraxzole (OPC-34712)

Drug: Brexpiprazole (OPC-34712)

Cohort 5

EXPERIMENTAL

4mg, Brexpipraxzole (OPC-34712)

Drug: Brexpiprazole (OPC-34712)

Interventions

Brexpiprazole (OPC-34712) DRUG

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.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female subjects 13 to 17 years of age, inclusive, at the time of informed consent.
• Subjects with a current diagnosis of primary schizophrenia spectrum or bipolar spectrum disorder, as defined by DSM-IV-TR criteria, and confirmed by K-SADS-PL.
• No psychiatric hospitalizations within the past 12 weeks.
• Subjects require treatment with antipsychotic medications.
• Subjects who have received previous outpatient antipsychotic treatment at an adequate dose for an adequate duration (at least 6 weeks) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months.
• Subjects with a body weight at Screening greater than or equal to 30 kg.

You may not qualify if:

• Sexually active females of childbearing potential and male subjects who are not practicing two different methods of birth control with their partner (or abstinence) during the trial and for 30 days after the last dose of trial medication
• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving trial drug.
• Subjects who have received continuous medication therapy to treat schizophrenia and schizophrenia spectrum diagnosis for less than six months prior to first dose of study medication AND subjects who have received continuous medication therapy to treat bipolar and bipolar spectrum disorder for less than two months in the past three years; or subjects who require more than one antipsychotic..
• Subjects with a current DSM-IV-TR diagnosis other than schizophrenia spectrum , bipolar spectrum, including any Axis I or Axis II (DSM-IV-TR) disorder.
• Subjects with a clinical presentation and/or history of any neurodevelopmental disorder
• Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days.
• Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic hepatitis B or C.
• Subjects with IDDM (ie, any subjects using insulin) are excluded. Subjects with non-IDDM may be eligible for the trial if their condition is stable.
• Subjects with epilepsy or a history of seizures.
• Any major surgery or blood transfusion within 30 days prior to first dose of trial medication.
• Subjects with a positive drug screen for cocaine or other illicit drugs, or alcohol are excluded and may not be retested or re-screened.
• Subjects who participated in a clinical trial and were exposed to IMP within the last 30 days or who participated in more than two interventional clinical trials within the past year.
• Subjects with a history of true allergic response (ie, not intolerance) to more than one class of medications.
• Inability to tolerate oral medication or swallow tablets.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• H. Lundbeck A/S: collaborator

Study Sites (10)

Unknown Facility

Little Rock, Arkansas, 72211, United States

Location

Unknown Facility

Culver City, California, 90230, United States

Location

Unknown Facility

Orange, California, 92858, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20016, United States

Location

Unknown Facility

Atlanta, Georgia, 30331, United States

Location

Unknown Facility

Marlton, New Jersey, 08053, United States

Location

Unknown Facility

Cincinnati, Ohio, 45219, United States

Location

Unknown Facility

Cleveland, Ohio, 44106, United States

Location

Unknown Facility

The Woodlands, Texas, 77381, United States

Location

Unknown Facility

Orem, Utah, 84058, United States

Location

Related Links

• Otsuka Clinical Trial Website
• Otsuka Clinical Trial Transparency

MeSH Terms

Conditions

Schizophrenia

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: April 8, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)