Clinical trial NCT03902574: Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Male
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-04
Enrollment: 21
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum (Peak) Plasma Concentration (Cmax) of Brexpiprazole
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours postdose
measure: Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Brexpiprazole
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: SOUSEIKAI Hakata clinic
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Osamu Sato
role: STUDY_DIRECTOR
References: