NCT03734302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

April 24, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

November 1, 2023

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

November 2, 2018

Last Update Submit

October 30, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

  • Steady-state peak time (Tss_max)

    Assessment of the steady-state peak time of Brexpiprazole

    Day1, Day2, Day10, Day11, Day12, Day13, Day14, Day15, Day16, Dv17, Day18, Day19, Dv21,Day23, Day25

  • Steady-state valley concentration(Css_min)

    Assessment of the steady-state valley concentration of Brexpiprazole

    Day1, Day2, Day10, Day11, Day12, Day13, Day14, Day15, Day16, Dv17, Day18, Day19, Dv21,Day23, Day25

  • Steady-state peak concentration (Css_max)

    Assessment of the steady-state peak concentration of Brexpiprazole

    Day1, Day2, Day10, Day11, Day12, Day13, Day14, Day15, Day16, Dv17, Day18, Day19, Dv21,Day23, Day25

  • Average steady-state plasma concentration (Css_av)

    Assessment of the average steady-state plasma concentration (Css\_av) of Brexpiprazole

    Day1, Day2, Day10, Day11, Day12, Day13, Day14, Day15, Day16, Dv17, Day18, Day19, Dv21,Day23, Day25

  • Half-life (t1/2, z)

    Assessment of the Half-life of Brexpiprazole

    Day1, Day2, Day10, Day11, Day12, Day13, Day14, Day15, Day16, Dv17, Day18, Day19, Dv21,Day23, Day25

  • Steady-state clearance (CLss/F)

    Assessment of the steady-state clearance of Brexpiprazole

    Day1, Day2, Day10, Day11, Day12, Day13, Day14, Day15, Day16, Dv17, Day18, Day19, Dv21,Day23, Day25

  • Area under steady state plasma concentration-time curve (AUC)ss

    Assessment of the area under steady state plasma concentration-time curve of Brexpiprazole

    Day1, Day2, Day10, Day11, Day12, Day13, Day14, Day15, Day16, Dv17, Day18, Day19, Dv21,Day23, Day25

  • Fluctuation index (DF)

    Assessment of the fluctuation index of Brexpiprazole

    Day1, Day2, Day10, Day11, Day12, Day13, Day14, Day15, Day16, Dv17, Day18, Day19, Dv21,Day23, Day25

  • Cumulative coefficient (RAUC, Rcmax)

    Assessment of the cumulative coefficient of Brexpiprazole

    Day1, Day2, Day10, Day11, Day12, Day13, Day14, Day15, Day16, Dv17, Day18, Day19, Dv21,Day23, Day25

Secondary Outcomes (4)

  • The peak concentration (Cmax) after the first administration

    Day1, Day2

  • The peak time (Tmax) after the first administration

    Day1, Day2

  • Area under the plasma concentration-time curve (AUC0-24h)

    Day1, Day2

  • Valley concentration points

    Day10, Day11, Day12, Day13, Day14

Study Arms (1)

Multiple dose oral administration

EXPERIMENTAL

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

Drug: Brexpiprazole

Interventions

BrexpiprazoleDRUG

Brexpiprazole , mutiple dose /oral/empty stomach

Also known as: Brex
Multiple dose oral administration

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. 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) \[ body mass index (BMI) = body weight (kg) / height2 (m2)\].

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, 100088, China

Location

MeSH Terms

Interventions

brexpiprazole

Study Officials

  • Tao Jiang, Master

    Beijing Anding Hospital of Capital Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 7, 2018

Study Start

April 24, 2019

Primary Completion

June 10, 2020

Study Completion

June 10, 2020

Last Updated

November 1, 2023

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)