Healthy VolunteersPhase 1NCT02584569
Phase 1 TAK-915 Single-Dose Positron Emission Tomography (PET) Occupancy Study
A Phase 1 study testing TAK-915 in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial summary
This phase 1 study will be conducted to examine the degree and duration of brain PDE2A enzyme occupancy /target engagement as a function of TAK-915 plasma concentration in order to guide dosing and schedule for future clinical studies in schizophrenia with TAK-915. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TAK-915
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Apr 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is a healthy male, or female of non-childbearing potential, aged between 18 and 55 years, inclusive.
- Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2.
Who cannot join
- Has a known history or evidence of a clinically significant disorder (including neurologic and psychiatric) or disease that in the opinion of the study investigator would pose a risk to the participant's safety or interfere with the study evaluation, procedures, or completion.
- Contraindication to magnetic resonance imaging (MRI) based on the standard MRI screening questionnaire.
- Have had exposure to any radiation >15 millisievert (mSv)/year (eg, occupational or radiation therapy) within the previous year prior to Baseline imaging.
- Has a known hypersensitivity to any component of the formulation of TAK-915 or related compounds, or to [18F]MNI-794 or to any of its components.
- Clinically significant abnormal findings on brain MRI scan or findings on brain MRI that may interfere with the interpretation of the positron emission tomography (PET) imaging.
- Use of any herbal or prescription medications within 30 days prior to Baseline Imaging Check-in; use of any over-the-counter medications or vitamin supplements within 7 days prior to Baseline Imaging Check-in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Positron Emission Tomography Study With [18F]MNI-794 to Determine Phosphodiesterase 2A Brain Enzyme Occupancy of TAK-915 After Single-Dose Oral Administration in Healthy Subjects
This phase 1 study will be conducted to examine the degree and duration of brain PDE2A enzyme occupancy /target engagement as a function of TAK-915 plasma concentration in order to guide dosing and schedule for future clinical studies in schizophrenia with TAK-915.
Read the detailed description
The drug being tested in this study is called TAK-915. TAK-915 is being tested to examine the degree and duration of brain phosphodiesterase 2A (PDE2A) enzyme occupancy/target engagement as a function of TAK-915 plasma concentration in order to guide dosing and schedule for future clinical studies in schizophrenia. This study will look at PDE2A brain enzyme occupancy in the putamen as a function of TAK-915 plasma concentration, as assessed using the positron emission tomography (PET) ligand [18F]MNI-794 after single dosing of TAK-915.
The study will enroll approximately 16 patients in total and within that total, allow up to 5 dose levels and up to 6 subjects per dose level. All participants will receive a single dose of TAK-915 on Day 1. The initial TAK-915 dose level to be studied is 100 mg. Subsequent dose levels may be lower or higher and will be determined through dose level review meetings (DLRMs) following approximately every 2 participants and based on prior occupancy, duration of occupancy, safety, tolerability, and available pharmacokinetic (PK) data.
This single center trial will be conducted in the United States. The overall time to participate in this study is up to 55 days. Participants will make multiple visits to the clinic, and will be contacted by telephone 22 days after last dose of study drug for a follow-up assessment.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-915
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-915Drug
TAK-915 oral suspension
| Study group | Role | What they receive |
|---|---|---|
| TAK-915 | Experimental | TAK-915 100 mg suspension, orally, once on Day 1. Additional TAK-915 dose levels may be incorporated based on dose level review meetings (DLRMs) following approximately every 2 participants and based on prior occupancy, duration of occupancy, safety, tolerability, and available pharmacokinetic (PK) data. Receives: Drug: TAK-915 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phosphodiesterase 2A (PDE2A) Brain Enzyme Occupancy in the Putamen as a Function of TAK-915 Plasma Concentration for each subject
Assessed for each subject using the PET ligand [18F]MNI-794 after single dosing of TAK-915, obtained from non-displaceable binding potential (BPnd).
Measured: 2 PET scans occurring on Day 1 or 1 PET scan on Day 1 and 1 on Day 2.
Secondary outcomes (2)
Plasma PK concentrations for each subject post tracer injection for each PET scan period following TAK-915 dosing
Measured: t=0, t=45 min and t=90 min (after tracer injection) during each PET scan period.
Dose and exposure of TAK-915 that correspond to PDE2A occupancy in the putamen of at least 45%.
Measured: At multiple time points (up to 90 minutes after tracer injection) during each PET scan period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584569
- Sponsor's protocol ID
- TAK-915-1002
- Other IDs
- U1111-1168-0766
- Status last verified
- Jul 2016
- First submitted
- 21 Oct 2015
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Positron Emission Tomography Study With [18F]MNI-794 to Determine Phosphodiesterase 2A Brain Enzyme Occupancy of TAK-915 After Single-Dose Oral Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02584569
- Acronym / sponsor ID
- TAK-915-1002
- Conditions
- Healthy Volunteers
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Oct 2015 (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.
This phase 1 study will be conducted to examine the degree and duration of brain PDE2A enzyme occupancy /target engagement as a function of TAK-915 plasma concentration in order to guide dosing and schedule for future clinical studies in schizophrenia with TAK-915.
Detailed description
The drug being tested in this study is called TAK-915. TAK-915 is being tested to examine the degree and duration of brain phosphodiesterase 2A (PDE2A) enzyme occupancy/target engagement as a function of TAK-915 plasma concentration in order to guide dosing and schedule for future clinical studies in schizophrenia. This study will look at PDE2A brain enzyme occupancy in the putamen as a function of TAK-915 plasma concentration, as assessed using the positron emission tomography (PET) ligand [18F]MNI-794 after single dosing of TAK-915.
The study will enroll approximately 16 patients in total and within that total, allow up to 5 dose levels and up to 6 subjects per dose level. All participants will receive a single dose of TAK-915 on Day 1. The initial TAK-915 dose level to be studied is 100 mg. Subsequent dose levels may be lower or higher and will be determined through dose level review meetings (DLRMs) following approximately every 2 participants and based on prior occupancy, duration of occupancy, safety, tolerability, and available pharmacokinetic (PK) data.
This single center trial will be conducted in the United States. The overall time to participate in this study is up to 55 days. Participants will make multiple visits to the clinic, and will be contacted by telephone 22 days after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-915 | Experimental | Drug: TAK-915TAK-915 100 mg suspension, orally, once on Day 1. Additional TAK-915 dose levels may be incorporated based on dose level review meetings (DLRMs) following approximately every 2 participants and based on prior occupancy, duration of occupancy, safety, tolerability, and available pharmacokinetic (PK) data. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is a healthy male, or female of non-childbearing potential, aged between 18 and 55 years, inclusive.
- Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2.
Key exclusion criteria (6 listed)
- Has a known history or evidence of a clinically significant disorder (including neurologic and psychiatric) or disease that in the opinion of the study investigator would pose a risk to the participant's safety or interfere with the study evaluation, procedures, or completion.
- Contraindication to magnetic resonance imaging (MRI) based on the standard MRI screening questionnaire.
- Have had exposure to any radiation >15 millisievert (mSv)/year (eg, occupational or radiation therapy) within the previous year prior to Baseline imaging.
- Has a known hypersensitivity to any component of the formulation of TAK-915 or related compounds, or to [18F]MNI-794 or to any of its components.
- Clinically significant abnormal findings on brain MRI scan or findings on brain MRI that may interfere with the interpretation of the positron emission tomography (PET) imaging.
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 |
|---|---|---|
| TAK-915TAK-915 oral suspension | Drug | TAK-915 |
Primary outcome
Phosphodiesterase 2A (PDE2A) Brain Enzyme Occupancy in the Putamen as a Function of TAK-915 Plasma Concentration for each subject
Time frame: 2 PET scans occurring on Day 1 or 1 PET scan on Day 1 and 1 on Day 2.
Assessed for each subject using the PET ligand [18F]MNI-794 after single dosing of TAK-915, obtained from non-displaceable binding potential (BPnd).
2 secondary outcomes
Plasma PK concentrations for each subject post tracer injection for each PET scan period following TAK-915 dosing
Time frame: t=0, t=45 min and t=90 min (after tracer injection) during each PET scan period.
Dose and exposure of TAK-915 that correspond to PDE2A occupancy in the putamen of at least 45%.
Time frame: At multiple time points (up to 90 minutes after tracer injection) during each PET scan period.
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 21 Jul 2016.
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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.
Medical Director Clinical Science study director
Takeda
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 TAK-915 in people with Healthy Volunteers, run by Takeda at 1 site in United States.
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 21 Jul 2016. 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 United States. 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?
Phosphodiesterase 2A (PDE2A) Brain Enzyme Occupancy in the Putamen as a Function of TAK-915 Plasma Concentration for each subject (time frame: 2 PET scans occurring on Day 1 or 1 PET scan on Day 1 and 1 on Day 2.). 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 21 Jul 2016.