A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses

NCT04118127 | Completed Phase 1 Results

• 1 other identifier: 331-102-00150
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia,brexpiprazole,open-label,linical pharmacology

Outcome Measures

Primary Outcomes (4)

• Maximum Plasma Concentration (Cmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1

  To evaluate Cmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .

  prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose

• Time to Maximum (Peak) Plasma Concentration (Tmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1

  To evaluate Tmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .

  prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose

• Cmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2

  To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.

  prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose

• Tmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2

  To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.

  prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose

Study Arms (1)

2mg conventional tablet, once-weekly tablets

EXPERIMENTAL

Drug: 2mg conventional tablet, once-weekly tablets

Interventions

2mg conventional tablet, once-weekly tablets DRUG

In each cohort, subjects will receive a brexpiprazole 2 mg conventional tablet on Day 1of Period 1, the QW formulation on Day 1 of Period 2 and 3, as single and multiple dose in a fasted state.

2mg conventional tablet, once-weekly tablets

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
• Patients capable of staying at the trial site from the day before investigational medicinal product (IMP) administration to the 8th day following IMP administration in both Period 1 and Period 2
• Patients with a body mass index \[BMI = body weight (kg)/height (m)2\] of 18.5 or higher and lower than 35.0 at screening
• Persons who provide written informed consent before commencement of any trial-related procedures and whom the investigator or subinvestigator judges to be capable of following all the conditions of this trial
• Patients who, in the judgement of the investigator or subinvestigator, have stable psychotic symptoms maintained by administration of an antipsychotic (other than clozapine) within the dosing range indicated separately, before commencement of investigational medicinal product (IMP) administration"

You may not qualify if:

• Patients who fail to meet the specified requisite washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of these drugs or foods during the study period
• Patients who have previously undergone gastrointestinal surgery that could affect pharmacokinetic evaluations
• Patients who are using clozapine at the time of informed consent
• Patients who have received electro-convulsive therapy within 60 days before commencement of IMP administration
• Patients with clinically problematic disorders of the nervous system, liver, kidneys, metabolic system, blood, immune system, cardiovascular system, lungs, or digestive system (However, such patients may be included if the condition is mild or well-controlled and is considered to not affect safety or pharmacokinetic evaluations.)

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sankeikai Nishigahara Hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Takehisa Matsumaru

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 8, 2019
• Study Start: October 17, 2019
• Primary Completion: February 16, 2021
• Study Completion: March 3, 2021
• Last Updated: August 5, 2024
• Results First Posted: August 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

JP (1)