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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Male

Treatments: Drug: OPC-34712

Study type: Interventional

Funder types: Industry

Identifiers

NCT02875080

331-102-00019

JapicCTI-163351 (Other Identifier)

Details and patient eligibility

About

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)).

Enrollment: 18 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

OPC-34712 disintegrating tablet with water

Experimental group

Description:

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

Treatment:

Drug: OPC-34712

OPC-34712 disintegrating tablet without water

Experimental group

Description:

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

Treatment:

Drug: OPC-34712

OPC-34712 conventional tablet with water

Experimental group

Description:

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

Treatment:

Drug: OPC-34712