The Pharmacokinetics, Tolerability and Safety of Brexpiprazole in Healthy Chinese Subjects

Otsuka

Status and phase: Completed; Phase 1

Conditions: Health

Treatments: Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03734354

331-403-00024

Details and patient eligibility

About

This study is a single-center, open-label study evaluating the pharmacokinetics, tolerability and safety of single dose oral brexpiprazole tablets in healthy Chinese subjects. A total of 30 healthy adult subjects are to be enrolled into the study. Three dose groups will be set up, with about 10 subjects in each dose group. Subjects will enter 1 mg, 2 mg and 4 mg dose groups in sequence.

Full description

A total of 30 healthy adult subjects are to be enrolled into the study. Three dose groups will be set up, with about 10 subjects in each dose group. Subjects will enter 1 mg, 2 mg and 4 mg dose groups in sequence.

After the clinical trial responsible physicians obtain the informed consent forms from subjects, the subjects will be screened 14 days to 1 days prior to taking the study drug (D-14~D-1).

One day prior to dosing in each group (D-1), the included subjects are hospitalized On the next day (D1), after completed the hospitalization inspection, eligible subjects will be assigned subject numbers to start with the first dose, complete corresponding examination, stay in hospital for observation and be discharged on Day 4 of medication. On days 6, 8, 10, 12 blood samples are collected and safety evaluation will be performed. Telephone follow-up will be performed on day Day31.

Blood samples are collected to determine and evaluate blood concentrations of Brexpiprazole and its main metabolite DM-3411 before dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours after dosing, with 18 sampling points in total.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Sign the informed consent form
• 2.At the age of 18~45 years old (including upper and lower limits) when signing the informed consent form.
• 3.Body weight of not less than 50kg, BMI 19 ~ 24kg/m2 (including the upper and lower limits) [ body mass index (BMI) = body weight (kg) / height2 (m2)].

Exclusion criteria

• 1. Participated in any interventional clinical trial within 12 weeks prior to enrollment.
• 2.Drug abuse in the past 2 years or a history of abuse
• 3.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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

1 mg dosing group

Experimental group

Description:

Dosing group 1, single/oral/with fasting, Brexpiprazole 1.0 mg, 1 tablets

Treatment:

Drug: Brexpiprazole

2 mg dosing group

Experimental group

Description:

Dosing group 2, single/oral/with fasting, Brexpiprazole 1.0 mg, 2 tablets

Treatment:

Drug: Brexpiprazole

4 mg dosing group

Experimental group

Description:

Dosing group 3, single/oral/with fasting, Brexpiprazole 1.0 mg, 4 tablets

Treatment:

Drug: Brexpiprazole