SchizophreniaPhase 1NCT00805454
Positron Emission Tomagraphy (PET) Study Following a Single Oral Dose of OPC-34712
A Phase 1 study testing OPC-34712 in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
Trial summary
Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht dose levels in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- OPC-34712
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Jul 2009
- 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
- Males and non-child bearing potential females between 18 and 45 years of age, inclusive.
- BMI between 19 and 32 kg/m2, inclusive.
Who cannot join
- Condition or history which may present a safety concern to the subject or interfere with outcome variables.
- History of or current drug or alcohol abuse, hepatitis, AIDS, or drug allergy.
- Use of prescription, over-the-counter, or herbal medication, or vitamin supplements within 14 days or antibiotics within 30 days.
- Use of tobacco products or daily exposue to second hand smoke.
- Blood pressure higher than 140/90 mmHg or lower than 100/50 mmHg: heart rate outside 40 to 90 beats/minute.
- History of serious mental disorder.
About this study
Official title: A Phase I, Open-Label,Positron Emission Tomography (PET) Study Healthy Subjects Following a Single Oral Dose of OPC-34712
Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht dose levels in healthy volunteers.
Read the detailed description
Subjects will receive a dose of study medication and will undergo a PET scan at 4 hrs and 23.5 hours post dose. Subjects will remain in the clinic from Day-1 to Day 7 for PK sample collection and safety monitoring. Subjects will return to the clinic on Day 10 for a follow-up safety assessment.
- Conditions
- Schizophrenia
- Being tested
- OPC-34712
- Keywords
- Healthy Volunteers, Phase I, Pet Scan
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-34712Drug
Single oral dose, 0.5 to 25 mg
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan.
Measured: 10 days
Secondary outcomes (1)
Measure safety: adverse events, vital signs, ECGs, and clinical laboratory tests
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.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
- Basic science
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Dean Wong, MD,PhD, Principal investigator, Johns Hopkins University, Baltimore,MD 21287Stephen Bart, MD, Principal investigator, SNBL, Baltimore,MD 21201
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805454
- Sponsor's protocol ID
- 331-07-202
- Status last verified
- May 2010
- First submitted
- 4 Dec 2008
- Last updated
- 7 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wong DF, Raoufinia A, Bricmont P, Brasic JR, McQuade RD, Forbes RA, Kikuchi T, Kuwabara H. An open-label, positron emission tomography study of the striatal D2/D3 receptor occupancy and pharmacokinetics of single-dose oral brexpiprazole in healthy participants. Eur J Clin Pharmacol. 2021 May;77(5):717-725. doi: 10.1007/s00228-020-03021-9. Epub 2020 Nov 16.
PubMed 33196868
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label,Positron Emission Tomography (PET) Study Healthy Subjects Following a Single Oral Dose of OPC-34712
- ClinicalTrials.gov ID
- NCT00805454
- Acronym / sponsor ID
- 331-07-202
- Conditions
- Schizophrenia
- Keywords
- Healthy Volunteers, Phase I, Pet Scan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Dec 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Dec 2008 (estimated)
- 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.
Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht dose levels in healthy volunteers.
Detailed description
Subjects will receive a dose of study medication and will undergo a PET scan at 4 hrs and 23.5 hours post dose. Subjects will remain in the clinic from Day-1 to Day 7 for PK sample collection and safety monitoring. Subjects will return to the clinic on Day 10 for a follow-up safety assessment.
Study design
- Primary purpose
- Basic science
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males and non-child bearing potential females between 18 and 45 years of age, inclusive.
- BMI between 19 and 32 kg/m2, inclusive.
Key exclusion criteria (6 listed)
- Condition or history which may present a safety concern to the subject or interfere with outcome variables.
- History of or current drug or alcohol abuse, hepatitis, AIDS, or drug allergy.
- Use of prescription, over-the-counter, or herbal medication, or vitamin supplements within 14 days or antibiotics within 30 days.
- Use of tobacco products or daily exposue to second hand smoke.
- Blood pressure higher than 140/90 mmHg or lower than 100/50 mmHg: heart rate outside 40 to 90 beats/minute.
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 |
|---|---|---|
| OPC-34712Single oral dose, 0.5 to 25 mg | Drug | – |
Primary outcome
Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan.
Time frame: 10 days
1 secondary outcome
Measure safety: adverse events, vital signs, ECGs, and clinical laboratory tests
Time frame: 30 days
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 7 May 2010.
- Derived from this study: PubMed 33196868Wong DF, Raoufinia A, Bricmont P, Brasic JR, McQuade RD, Forbes RA, Kikuchi T, Kuwabara H. An open-label, positron emission tomography study of the striatal D2/D3 receptor occupancy and pharmacokinetics of single-dose oral brexpiprazole in healthy participants. Eur J Clin Pharmacol. 2021 May;77(5):717-725. doi: 10.1007/s00228-020-03021-9. Epub 2020 Nov 16.
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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.
Dean Wong, MD,PhD principal investigator
Johns Hopkins University, Baltimore,MD 21287
Stephen Bart, MD principal investigator
SNBL, Baltimore,MD 21201
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPC-34712 in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
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 2 inclusion and 6 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 7 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan. (time frame: 10 days). 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 NCT00805454, which also lists 1 linked publication.
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 7 May 2010.