Healthy Adult MalePhase 1NCT03902574
Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg
A Phase 1 study testing Brexpiprazole ODT 2mg with water, Brexpiprazole ODT 2mg without water and Brexpiprazole conventional tablet 2mg in people with Healthy Adult Male, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg Read more about this study
- Who is it for?
- Ages 20 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- Brexpiprazole ODT 2mg with water, Brexpiprazole ODT 2mg without water and Brexpiprazole conventional tablet 2mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteJapan
- Study dates
- 27 Mar 2019to 18 Jun 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese males
- BMI ［body weight in kg /(height in m)2］ of at least 18.5 kg/m2 and less than 25.0 kg/m2 (as a result of at the screening examination)
- Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial
Who cannot join
- Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator, subinvestigator, or sponsor may place the subject at risk or interfere with outcome variables such as drug absorption, distribution, metabolism, and excretion
- History of serious mental disorder
- History of drug or alcohol abuse within 2 years prior to screening
- History of any significant drug allergy
- Use of another investigational drug within 120 days prior to the first administration of IMP
- Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, Star fruit, or Star fruit products within 72 hours prior to the first administration of IMP or consumption of alcohol within 72 hours prior to administration of IMP
Show all 9Show fewer
- Use of prescription, over-the-counter (OTC), or herbal medication, or vitamin supplements, or consumption of food or beverages containing St. John's Wort within 14 days prior to the first administration of IMP, or use of antibiotics within 30 days prior to the first administration of IMP
- History of major surgery of the digestive tract (excluding appendectomy)
- Any subject who, in the judgement of the investigator or subinvestigator, should not participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-label, Randomized, 3-arm, 3-way, Crossover Trial to Investigate the Bioequivalence of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets in Healthy Adult Males
To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg
- Conditions
- Healthy Adult Male
- Being tested
- Brexpiprazole ODT 2mg with water, Brexpiprazole ODT 2mg without water, Brexpiprazole conventional tablet 2mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brexpiprazole ODT 2mg with waterDrug
Also called OPC-34712 OD
Brexpiprazole ODT 2mg is administered with water.
Brexpiprazole ODT 2mg without waterDrug
Also called OPC-34712 OD
Brexpiprazole ODT 2mg is administered without water.
Brexpiprazole conventional tablet 2mgDrug
Also called OPC-34712 conventional tablet
Brexpiprazole conventional tablet 2mg is administered with water.
| Study group | Role | What they receive |
|---|---|---|
| Brexpiprazole ODT 2mg with water | Experimental | Brexpiprazole ODT 2mg is administered with water. Receives: Drug: Brexpiprazole ODT 2mg with water |
| Brexpiprazole ODT 2mg without water | Experimental | Brexpiprazole ODT 2mg is administered without water. Receives: Drug: Brexpiprazole ODT 2mg without water |
| Brexpiprazole conventional tablet 2mg | Experimental | Brexpiprazole conventional tablet 2mg is administered with water. Receives: Drug: Brexpiprazole conventional tablet 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum (Peak) Plasma Concentration (Cmax) of Brexpiprazole
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours postdose
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Brexpiprazole
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start27 Mar 2019
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Osamu Sato, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902574
- Sponsor's protocol ID
- 331-14-002
- Other IDs
- JapicCTI-194655
- Status last verified
- Jun 2021
- First submitted
- 2 Apr 2019
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, Randomized, 3-arm, 3-way, Crossover Trial to Investigate the Bioequivalence of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets in Healthy Adult Males
- ClinicalTrials.gov ID
- NCT03902574
- Acronym / sponsor ID
- 331-14-002
- Conditions
- Healthy Adult Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Posted 20 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brexpiprazole ODT 2mg with water | Experimental | Drug: Brexpiprazole ODT 2mg with waterBrexpiprazole ODT 2mg is administered with water. |
| Brexpiprazole ODT 2mg without water | Experimental | Drug: Brexpiprazole ODT 2mg without waterBrexpiprazole ODT 2mg is administered without water. |
| Brexpiprazole conventional tablet 2mg | Experimental | Drug: Brexpiprazole conventional tablet 2mgBrexpiprazole conventional tablet 2mg is administered with water. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Japanese males
- BMI ［body weight in kg /(height in m)2］ of at least 18.5 kg/m2 and less than 25.0 kg/m2 (as a result of at the screening examination)
- Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial
Key exclusion criteria (9 listed)
- Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator, subinvestigator, or sponsor may place the subject at risk or interfere with outcome variables such as drug absorption, distribution, metabolism, and excretion
- History of serious mental disorder
- History of drug or alcohol abuse within 2 years prior to screening
- History of any significant drug allergy
- Use of another investigational drug within 120 days prior to the first administration of IMP
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 |
|---|---|---|
| Brexpiprazole ODT 2mg with waterAlso: OPC-34712 ODBrexpiprazole ODT 2mg is administered with water. | Drug | Brexpiprazole ODT 2mg with water |
| Brexpiprazole ODT 2mg without waterAlso: OPC-34712 ODBrexpiprazole ODT 2mg is administered without water. | Drug | Brexpiprazole ODT 2mg without water |
| Brexpiprazole conventional tablet 2mgAlso: OPC-34712 conventional tabletBrexpiprazole conventional tablet 2mg is administered with water. | Drug | Brexpiprazole conventional tablet 2mg |
Primary outcome
Maximum (Peak) Plasma Concentration (Cmax) of Brexpiprazole
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours postdose
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Brexpiprazole
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Osamu Sato study director
Otsuka Pharmaceutical Co., Ltd.
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 ODT 2mg with water, Brexpiprazole ODT 2mg without water and Brexpiprazole conventional tablet 2mg in people with Healthy Adult Male, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
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 9 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 20 Jul 2021. 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 Japan. 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?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum (Peak) Plasma Concentration (Cmax) of Brexpiprazole (time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12,16, 24, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours postdose). The study lists 2 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 20 Jul 2021.