A Single-center, Open-label Study Evaluating the Pharmacokinetics, and Safety of Multiple Dose Oral Brexpiprazole Tablets (1 mg) in Chinese Healthy Subjects

Otsuka Beijing Research Institute1 site in 1 country10 target enrollmentApril 24, 2019

ConditionsHealthy

InterventionsBrexpiprazole

DrugsBrexpiprazole

Overview

Phase: Phase 1
Intervention: Brexpiprazole
Conditions: Healthy
Sponsor: Otsuka Beijing Research Institute
Enrollment: 10
Locations: 1
Primary Endpoint: Steady-state clearance (CLss/F)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a single-center, open-label study evaluating the pharmacokinetics and safety of multiple dose oral administration of Brexpiprazole (1 mg) tablets in Chinese healthy subject.10 healthy adult subjects will be enrolled in this study. A single dose (Brexpiprazole 1 mg) group is set and the test drug will be administered for 14 consecutive days.

Detailed Description

10 healthy adult subjects will be enrolled in this study. A single dose (Brexpiprazole 1 mg) group is set and the test drug will be administered for 14 consecutive days. After receiving the informed consent form the subject themselves, the investigators start the screening 14 days to 1 days prior to taking the study drug (D-14 to D-1). One day before first dosing (D-1), subjects are hospitalized. On the next day (D1), after completed the hospitalization inspection, eligible subjects will be selected to start with the first dose, and from day 1 to day 14 (D1 to D14), continue once daily dosing and complete the corresponding inspection, observation and blood sampling. They continue hospitalization and are discharged on day 17 (D17) after completing the relevant examinations. On days 19, 21, 23，25 (D19, D21，D23 and D25), blood samples are collected and safety evaluation is performed. Telephone follow-up is performed on day 44 (D44, 30 days after the last dose of the drug). Subjects who early terminated the test after taking the study drug should be tested at the end of the study (D25/ET) as far as possible. Blood samples for pharmacokinetic evaluation are collected before daily dosing; D1 (before dosing, and 1, 2, 3, 4, 5, 6, 8, 12 hours after dosing), D2 (before dosing and 24 hours after first dosing), D10 (before dosing), D11 (before dosing), D12 (before dosing), D13 (before dosing), D14 (before dosing, and 1, 2, 3, 4, 5, 6, 8, 12 hours after dosing), D15 (24 hours after last dosing), D16 (48 hours after last dosing), D17 (72 hours after last dosing), D18 (96 hours after last dosing), D19 (120 hours after last dosing), D21 (168 hours after last dosing),D23 (216 hours after last dosing), D25 (264 hours after last dosing). 31 Blood samples collecting points in total.

Registry

clinicaltrials.gov

Start Date

April 24, 2019

End Date

June 10, 2020

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Otsuka Beijing Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Sign the informed consent form
•At the age of 18\~45 years old (including upper and lower limits).
•Body weight of not less than 45 kg, body mass index 19 \~ 25kg/m2 range (including the upper and lower limits) \[ body mass index (BMI) = body weight (kg) / height2 (m2)\].

Exclusion Criteria

•Participated in any drug test within 12 weeks prior to enrollment.
•Drug abuse in the past 2 years or a history of substance abuse.
•Drinking alcohol more than 2 unit per day (1 unit= 360 ml beer , or 45 ml 4.0% alcohol, or 150 ml liquor, or 50 ml wine ) 6 months before the screening, or subjects can not stop drinking during the hospitalization.
•Drug abuse urine test at screening is positive.
•Other protocol-defined inclusion and exclusion criteria may apply.

Arms & Interventions

Multiple dose oral administration

1mg Once Daily (QD) , oral administration,14 consecutive days

Intervention: Brexpiprazole