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

Healthy Adult Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875080
• Other study ID #: 331-102-00019
• Secondary ID: JapicCTI-163351
• Status: Completed
• Phase: Phase 1
• Start date: September 27, 2016
• Est. completion date: November 27, 2016

Study information

• Verified date: February 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 27, 2016
• Est. primary completion date: November 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adult Male

Intervention

Drug:
• OPC-34712

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Area Under the Concentration-time Curve From Time Zero to Infinity (AUC8) of OPC-34712	To evaluate AUC8 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