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

Study Overview
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Brief Summary
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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)).

Official Title
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A Single-center, Open-label, Randomized, Three-way, Crossover Trial to Evaluate the Bioavailability of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets Relative to Brexpiprazole (OPC-34712) Conventional Tablets in Healthy Male Subjects

Conditions
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Healthy Adult Male

Intervention / Treatment
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* Drug: OPC-34712


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-34712 disintegrating tablet with water<br>OPC-34712 (4 mg) orally disintegrating tablet is administered with water. | Drug: OPC-34712<br> <br> * Other names: Brexpiprazole;|
| Experimental: OPC-34712 disintegrating tablet without water<br>OPC-34712 (4 mg) orally disintegrating tablet is administered without water. | Drug: OPC-34712<br> <br> * Other names: Brexpiprazole;|
| Experimental: OPC-34712 conventional tablet with water<br>OPC-34712 (4 mg) conventional tablet is administered with water. | Drug: OPC-34712<br> <br> * Other names: Brexpiprazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |