HealthPhase 1NCT03734354
The Pharmacokinetics, Tolerability and Safety of Brexpiprazole in Healthy Chinese Subjects
A Phase 1 study testing Brexpiprazole in people with Health, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health
- 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2019to 18 May 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) 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)].
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, 100088
About this study
Official title: A Single-center, Open-label Study Evaluating the Pharmacokinetics, Tolerability and Safety of Single Dose Oral Brexpiprazole Tablets in Healthy Chinese Subjects
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.
Read the detailed 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.
- Conditions
- Health
- 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 , single/oral/with fasting
| Study group | Role | What they receive |
|---|---|---|
| 1 mg dosing group | Experimental | Dosing group 1, single/oral/with fasting, Brexpiprazole 1.0 mg, 1 tablets Receives: Drug: Brexpiprazole |
| 2 mg dosing group | Experimental | Dosing group 2, single/oral/with fasting, Brexpiprazole 1.0 mg, 2 tablets Receives: Drug: Brexpiprazole |
| 4 mg dosing group | Experimental | Dosing group 3, single/oral/with fasting, Brexpiprazole 1.0 mg, 4 tablets Receives: Drug: Brexpiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak concentration (Cmax) after the first administration
The peak concentration (Cmax) of Brexipiprazole and the metabolite DM-3411 after administration
Measured: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
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: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
Area under the plasma concentration-time curve (AUC0-264h)
The area under the plasma concentration-time curve of Brexipiprazole after administration are calculated.
Measured: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
Half time after the first administration
The half time of Brexipiprazole after administration are calculated.
Measured: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
Apparent clearance after the first administration
To assess the apparent clearance after administration (CL/F) of Brexipiprazole after the first administration
Measured: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of OPC-34712
To assess the Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of OPC-34712
Measured: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
Secondary outcomes (7)
Blood pressure
To seeess blood pressure after administration of brexpiprazole
Measured: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
Heart rate
To seeess heart rate after administration of brexpiprazole
Measured: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
Body weight
To seeess Body weight after administration of brexpiprazole
Measured: 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
12-lead ECG
To seeess 12-lead ECG after administration of brexpiprazole
Measured: 3, 6, 24, 72, 96, 120, 264 hours
Blood biochemistry
To seeess blood biochemistry after administration of brexpiprazole
Measured: 24, 96, 264 hours
Blood routine
To seeess blood routine after administration of brexpiprazole
Measured: 24, 96, 264 hours
urinary routine
To seeess urinary routine after administration of brexpiprazole
Measured: 24, 96, 264 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start7 Apr 2019
- Primary completion18 May 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao Jiang, Master, Principal investigator, Beijing Anding Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734354
- Sponsor's protocol ID
- 331-403-00024
- Status last verified
- Jul 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label Study Evaluating the Pharmacokinetics, Tolerability and Safety of Single Dose Oral Brexpiprazole Tablets in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT03734354
- Acronym / sponsor ID
- 331-403-00024
- Conditions
- Health
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2019 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 mg dosing group | Experimental | Drug: BrexpiprazoleDosing group 1, single/oral/with fasting, Brexpiprazole 1.0 mg, 1 tablets |
| 2 mg dosing group | Experimental | Drug: BrexpiprazoleDosing group 2, single/oral/with fasting, Brexpiprazole 1.0 mg, 2 tablets |
| 4 mg dosing group | Experimental | Drug: BrexpiprazoleDosing group 3, single/oral/with fasting, Brexpiprazole 1.0 mg, 4 tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)].
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrexpiprazoleAlso: BrexBrexpiprazole , single/oral/with fasting | Drug | 1 mg dosing group, 2 mg dosing group, 4 mg dosing group |
Primary outcome
The peak concentration (Cmax) after the first administration
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
The peak concentration (Cmax) of Brexipiprazole and the metabolite DM-3411 after administration
The peak time (Tmax) after the first administration
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
The peak-time of Brexipiprazole and the metabolite DM-3411 on the first day after administration are calculated.
Area under the plasma concentration-time curve (AUC0-264h)
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
The area under the plasma concentration-time curve of Brexipiprazole after administration are calculated.
Half time after the first administration
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
The half time of Brexipiprazole after administration are calculated.
Apparent clearance after the first administration
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
To assess the apparent clearance after administration (CL/F) of Brexipiprazole after the first administration
Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of OPC-34712
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
To assess the Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of OPC-34712
7 secondary outcomes
Blood pressure
Time frame: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
Heart rate
Time frame: 0, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
Body weight
Time frame: 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours
12-lead ECG
Time frame: 3, 6, 24, 72, 96, 120, 264 hours
Blood biochemistry
Time frame: 24, 96, 264 hours
Blood routine
Time frame: 24, 96, 264 hours
urinary routine
Time frame: 24, 96, 264 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Jiang, Master principal investigator
Beijing Anding Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brexpiprazole in people with Health, 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 3 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?
The peak concentration (Cmax) after the first administration (time frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.