Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects

NCT ID: NCT02875080

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-27
• Study Completion Date: 2016-11-27

Brief Summary

The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).

Conditions

Healthy Adult Male

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OPC-34712 disintegrating tablet with water

OPC-34712 (4 mg) orally disintegrating tablet is administered with water.

Group Type: EXPERIMENTAL

OPC-34712

Intervention Type: DRUG

OPC-34712 disintegrating tablet without water

OPC-34712 (4 mg) orally disintegrating tablet is administered without water.

Group Type: EXPERIMENTAL

OPC-34712

Intervention Type: DRUG

OPC-34712 conventional tablet with water

OPC-34712 (4 mg) conventional tablet is administered with water.

Group Type: EXPERIMENTAL

OPC-34712

Intervention Type: DRUG

Interventions

OPC-34712

Intervention Type: DRUG

Other Intervention Names

Brexpiprazole

Eligibility Criteria

Inclusion Criteria

• Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial

Exclusion Criteria

• Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator or sponsor may place the subject at risk or interfere with outcome variables, including drug absorption, distribution, metabolism, and excretion
• History of serious mental disorder
• History of drug or alcohol abuse within 2 years prior to screening
• History of any significant drug allergy
• Use of an investigational drug within 120 days prior to the first dosing of trial drug
• Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to screening
• Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, starfruit, or starfruit products within 72 hours prior to dosing
• Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or St. John's Wort within 14 days prior to the first dosing of trial drug, or of antibiotics within 30 days prior to the first dosing of trial drug
• History of major surgery of the digestive tract (excluding appendectomy)
• Any subject who, in the opinion of the investigator, should not participate in the trial

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroaki Ono, Mr

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Kyusyu Region, , Japan

Countries

Japan

Other Identifiers

JapicCTI-163351

Identifier Type: OTHER

Identifier Source: secondary_id

331-102-00019

Identifier Type: -

Identifier Source: org_study_id