Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg

NCT03902574 | Completed Phase 1 Results

• 2 other identifiers: 331-14-002JapicCTI-194655
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg

Conditions

Healthy Adult Male

Outcome Measures

Primary Outcomes (2)

• Maximum (Peak) Plasma Concentration (Cmax) of Brexpiprazole

  Pre-dose, 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 Calculated to the Last Observable Concentration at Time t (AUCt) of Brexpiprazole

  Pre-dose, 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)

Brexpiprazole ODT 2mg with water

EXPERIMENTAL

Brexpiprazole ODT 2mg is administered with water.

Drug: Brexpiprazole ODT 2mg with water

Brexpiprazole ODT 2mg without water

EXPERIMENTAL

Brexpiprazole ODT 2mg is administered without water.

Drug: Brexpiprazole ODT 2mg without water

Brexpiprazole conventional tablet 2mg

EXPERIMENTAL

Brexpiprazole conventional tablet 2mg is administered with water.

Drug: Brexpiprazole conventional tablet 2mg

Interventions

Brexpiprazole ODT 2mg with water DRUG

Brexpiprazole ODT 2mg is administered with water.

Also known as: OPC-34712 OD

Brexpiprazole ODT 2mg with water

Brexpiprazole ODT 2mg without water DRUG

Brexpiprazole ODT 2mg is administered without water.

Also known as: OPC-34712 OD

Brexpiprazole ODT 2mg without water

Brexpiprazole conventional tablet 2mg DRUG

Brexpiprazole conventional tablet 2mg is administered with water.

Also known as: OPC-34712 conventional tablet

Brexpiprazole conventional tablet 2mg

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Japanese males
• BMI ［body weight in kg /(height in m)2］ of at least 18.5 kg/m2 and less than 25.0 kg/m2 (as a result of at the screening examination)
• 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, subinvestigator, or sponsor may place the subject at risk or interfere with outcome variables such as 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 another investigational drug within 120 days prior to the first administration of IMP
• Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, Star fruit, or Star fruit products within 72 hours prior to the first administration of IMP or consumption of alcohol within 72 hours prior to administration of IMP
• Use of prescription, over-the-counter (OTC), or herbal medication, or vitamin supplements, or consumption of food or beverages containing St. John's Wort within 14 days prior to the first administration of IMP, or use of antibiotics within 30 days prior to the first administration of IMP
• History of major surgery of the digestive tract (excluding appendectomy)
• Any subject who, in the judgement of the investigator or subinvestigator, should not participate in the trial

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

SOUSEIKAI Hakata clinic

Fukuoka, Japan

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

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

• Osamu Sato

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

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: March 27, 2019
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: July 20, 2021
• Results First Posted: July 20, 2021

Record last verified: 2021-06

Locations

JP (1)