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

NCT02875080 | Completed Phase 1 Results

• 2 other identifiers: 331-102-00019JapicCTI-163351
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (Cmax) of OPC-34712

  To evaluate Cmax of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation

  Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120，144, 168, 216, 264, and 312 hours postdose

• Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) of OPC-34712

  To evaluate AUC∞ of OPC-34712 4-mg ODT formulation relative to 4-mg conventional tablet formulation

  Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120，144, 168, 216, 264, and 312 hours postdose

Study Arms (3)

OPC-34712 disintegrating tablet with water

EXPERIMENTAL

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

Drug: OPC-34712

OPC-34712 disintegrating tablet without water

EXPERIMENTAL

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

Drug: OPC-34712

OPC-34712 conventional tablet with water

EXPERIMENTAL

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

Drug: OPC-34712

Interventions

OPC-34712 DRUG

Also known as: Brexpiprazole

OPC-34712 conventional tablet with water; OPC-34712 disintegrating tablet with water; OPC-34712 disintegrating tablet without water

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kyusyu Region, Japan

Location

MeSH Terms

Interventions

brexpiprazole

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

• Hiroaki Ono, Mr

  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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 23, 2016
• Study Start: September 27, 2016
• Primary Completion: November 27, 2016
• Study Completion: November 27, 2016
• Last Updated: February 23, 2021
• Results First Posted: February 23, 2021

Record last verified: 2021-02

Locations

JP (1)