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

Study Overview
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Brief Summary
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To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg

Official Title
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A Single Center, Open-label, Randomized, 3-arm, 3-way, Crossover Trial to Investigate the Bioequivalence of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets in Healthy Adult Males

Conditions
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Healthy Adult Male

Intervention / Treatment
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* Drug: Brexpiprazole ODT 2mg with water
* Drug: Brexpiprazole ODT 2mg without water
* Drug: Brexpiprazole conventional tablet 2mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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, 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brexpiprazole ODT 2mg with water<br>Brexpiprazole ODT 2mg is administered with water. | Drug: Brexpiprazole ODT 2mg with water<br>* Brexpiprazole ODT 2mg is administered with water.<br>* Other names: OPC-34712 OD;|
| Experimental: Brexpiprazole ODT 2mg without water<br>Brexpiprazole ODT 2mg is administered without water. | Drug: Brexpiprazole ODT 2mg without water<br>* Brexpiprazole ODT 2mg is administered without water.<br>* Other names: OPC-34712 OD;|
| Experimental: Brexpiprazole conventional tablet 2mg<br>Brexpiprazole conventional tablet 2mg is administered with water. | Drug: Brexpiprazole conventional tablet 2mg<br>* Brexpiprazole conventional tablet 2mg is administered with water.<br>* Other names: OPC-34712 conventional tablet;|

What is the study measuring?
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Primary Outcome Measures

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