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HealthyPhase 1NCT03734302

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

A Phase 1 study testing Brexpiprazole in people with Healthy, run by Otsuka Beijing Research Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Brexpiprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
24 Apr 2019to 10 Jun 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1. Sign the informed consent form
  • 2. At the age of 18~45 years old (including upper and lower limits).
  • 3. 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)].

Who cannot join

  • 1. Participated in any drug test within 12 weeks prior to enrollment.
  • 2. Drug abuse in the past 2 years or a history of substance 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.
  • 4. Drug abuse urine test at screening is positive.
  • Other protocol-defined inclusion and exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Anding Hospital of Capital Medical University

    Beijing, Beijing Municipality, 100088

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Healthy
Being tested
Brexpiprazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrexpiprazoleDrug

    Also called Brex

    Brexpiprazole , mutiple dose /oral/empty stomach

Study groups in NCT03734302
Study groupRoleWhat they receive
Multiple dose oral administrationExperimental1mg Once Daily (QD) , oral administration,14 consecutive days
Receives: Drug: Brexpiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Steady-state peak time (Tss_max)

    Assessment of the steady-state peak time of Brexpiprazole

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

  2. Steady-state valley concentration(Css_min)

    Assessment of the steady-state valley concentration of Brexpiprazole

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

  3. Steady-state peak concentration (Css_max)

    Assessment of the steady-state peak concentration of Brexpiprazole

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

  4. Average steady-state plasma concentration (Css_av)

    Assessment of the average steady-state plasma concentration (Css_av) of Brexpiprazole

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

  5. Half-life (t1/2, z)

    Assessment of the Half-life of Brexpiprazole

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

  6. Steady-state clearance (CLss/F)

    Assessment of the steady-state clearance of Brexpiprazole

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

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

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

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

  8. Fluctuation index (DF)

    Assessment of the fluctuation index of Brexpiprazole

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

  9. Cumulative coefficient (RAUC, Rcmax)

    Assessment of the cumulative coefficient of Brexpiprazole

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

Secondary outcomes (4)

  1. The peak concentration (Cmax) after the first administration

    The peak concentration (Cmax) of Brexipiprazole and the metabolite DM-3411 on the first day after administration are calculated.

    Measured: Day1, Day2

  2. The peak time (Tmax) after the first administration

    The peak-time of Brexipiprazole and the metabolite DM-3411 on the first day after administration are calculated.

    Measured: Day1, Day2

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

    The area under the plasma concentration-time curve of Brexipiprazole and the metabolite DM-3411 on the first day after administration are calculated.

    Measured: Day1, Day2

  4. Valley concentration points

    Descriptive statistics about the valley concentration points before taking the study drug on days 10, 11, 12, 13 and 14

    Measured: Day10, Day11, Day12, Day13, Day14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start24 Apr 2019
  3. Primary completion10 Jun 2020
  4. Study completion10 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03734302
Sponsor's protocol ID
331-403-00025
Status last verified
Jan 2020
First submitted
2 Nov 2018
Last updated
1 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Brexpiprazole in people with Healthy, run by Otsuka Beijing Research Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steady-state peak time (Tss_max) (time frame: Day1, Day2, Day10, Day11, Day12, Day13, Day14, Day15, Day16, Dv17, Day18, Day19, Dv21,Day23, Day25). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03734302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.

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Clinical Trial NCT03734302 | AzTrials