To Determine Brain Target Occupancy of BPN14770Phase 1NCT04044781
A Phase 1, Open-Label, PET Study of T2310 & BPN14770
A Phase 1 study testing BPN14770, T2310 in people with To Determine Brain Target Occupancy of BPN14770, run by Tetra Discovery Partners at 1 site in United States.
Trial summary
This is a sponsor initiated, single site, first-in-human study of an investigational imaging agent for quantifying the topographically specific concentrations of the phosphodiesterase enzyme Type 4D (PDE4D) with positron emission tomography (PET) using a selective radioligand, [11C]T2310. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- To Determine Brain Target Occupancy of BPN14770
- What is being tested?
- BPN14770, T2310
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 30 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Willing and able to provide written informed consent.
- 2. Subjectively healthy
- 3. Between 18 and 75 years, inclusive, but preference will be given to subjects who are less than 55 years old.
- 4. The subject weighs at least 45 kg and has a body mass index between 18.0 and 32 kg/m2.
- 5. Subjects should be willing to observe the following contraception requirements from Screening until 90 days after the final follow-up visit: Male subjects must be willing to inform female partners of their participation in the study and must agree to use adequate contraceptive methods (vasectomy performed at least 6 months prior to dosing BPN14770 or use at least one barrier method of birth control). Female subjects: Female subjects must be surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to dosing of BPN14770), at least two years post-menopausal, or willing to use one barrier plus a hormonal contraceptive method of contraception from initial screening until one month after taking the last dose of study drug
Who cannot join
- 1. Known history or evidence of a clinically significant medical condition, disorder, or disease that, in the opinion of the investigator, would pose a risk to subject safety, proper completion of the procedures, or the integrity of the study.
- 2. Clinical laboratory studies suggestive of a medically meaningful disease or condition that, in the opinion of the investigator, could pose a risk to subject safety, proper completion of the procedures, or the integrity of the study.
- 3. Contraindication to MRI based on the standard MRI screening questionnaire at CBIC. Contraindications include ferromagnetic foreign bodies (e.g., shrapnel, ferromagnetic sheet metal fragments in the orbital area), certain implanted medical devices (e.g., older aneurysm clips, cardiac pacemakers), or claustrophobia.
- 4. Unexpected findings on screening MRI that are indicative of an occult brain disease, or will potentially compromise subject safety or the scientific integrity of the study data.
- 5. Previous exposure to ionizing radiation for research purposes, such that, in combination with the exposure from this study, their exposure to research associated radiation will be >50 mSv/year for the previous year.
- 6. Subjects who are atopic, or have a known hypersensitivity to any component of the formulation of BPN14770 or to [11C]T2310 PET scan.
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- 7. History of substance dependence, or current use of drugs of abuse.
- 8. History of regular weekly alcohol consumption >21 units for male subjects or >14units for female subjects or unable to abstain from alcohol from 24 hours prior to Screening visits and 24 hours prior to Period 2 Day (-1) until discharge at the end of Period 2.
- 9. Female subjects who are pregnant or lactating. 10. Use of any prescription drugs within 14 days or 5 half-lives (whichever is longer) before the first dose of an investigational product, unless in the opinion of the investigator (or delegate) and the Sponsor's Medical Monitor the medication will not interfere with the study procedures, the pharmacokinetics of either the radiopharmaceutical or the investigational drug product, or compromise subject safety. An example of potentially acceptable drug use might be beta blockers in eye drops for glaucoma.
- 11. Use of any non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) before the first dose of the study agents, unless in the opinion of the Investigator (or delegate) and the Sponsor's Medical Monitor the medication will not interfere with the study procedures, the pharmacokinetics of either the radiopharmaceutical or the investigational drug product, or compromise subject safety.
- 12. Subjects who have received an investigational drug as part in another study within the last 30 days or 5 half-lives of the investigational drug for the previous study (whichever is longer).
- 13. History of acquired immunodeficiency syndrome (AIDS).
- 14. Poor peripheral venous access.
- 15. Donation of ≥450 mL blood or loss of blood during surgery within 30 days prior to Day 1.
- 16. Plasma donation >100 mL within 7 days prior to Day 1.
- 17. In the Investigator's judgement it is better for the subject not to be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Positron Emission Tomography Study in Healthy Subjects to Determine the Relationship Between Plasma Concentration and Brain Target Occupancy of BPN14770
This is a sponsor initiated, single site, first-in-human study of an investigational imaging agent for quantifying the topographically specific concentrations of the phosphodiesterase enzyme Type 4D (PDE4D) with positron emission tomography (PET) using a selective radioligand, [11C]T2310. T2310 will be measured with imaging techniques to characterize plasma exposure levels versus regionally specific target engagement fractions for oral doses of BPN14770, an investigational new drug (IND) for modulating PDE4D. BPN14770 is under evaluation for the treatment of Fragile X syndrome and Alzheimer's disease.
- Being tested
- BPN14770, T2310
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPN14770, T2310Drug
Subjects will be administered radio ligand T2310 and BPN14770 to determine brain occupancy of BPN14770.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Stage 1 safety assessments will be performed before and after the administration of a single, 185 MBq (5mCi) dose of T2310 in up to three healthy volunteers. Stage 2 will evaluate the relationship between plasma concentration of BPN14770, an investigational PDE4D modulator, and brain target occupancy in up to six healthy volunteers. Receives: Drug: BPN14770, T2310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
To assess the safety and tolerability of [11C]T2310 when administered alone and when co-administered with BPN14770
Measured: 1-8 Days
Plasma Concentration
To determine relationships between plasma concentrations of BPN14770 and the total volume of distribution of T2310 as a proxy for brain PDE4D occupancy by BPN14770 following single oral dosing regimens of BPN14770 over a 24 hour time
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start10 Jan 2020
- Primary completion30 Apr 2020
- Study completion30 May 2020
Why it stopped: Change in Research Direction
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine Brain Target Occupancy of BPN14770Studies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetra Discovery Partners
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul D Mozley, MD, Principal investigator, Weill Cornell College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044781
- Sponsor's protocol ID
- T2310-PET-102
- Status last verified
- Dec 2021
- First submitted
- 2 Aug 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Positron Emission Tomography Study in Healthy Subjects to Determine the Relationship Between Plasma Concentration and Brain Target Occupancy of BPN14770
- ClinicalTrials.gov ID
- NCT04044781
- Acronym / sponsor ID
- T2310-PET-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in Research Direction
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tetra Discovery PartnersIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 5 Aug 2019 (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 is a sponsor initiated, single site, first-in-human study of an investigational imaging agent for quantifying the topographically specific concentrations of the phosphodiesterase enzyme Type 4D (PDE4D) with positron emission tomography (PET) using a selective radioligand, [11C]T2310. T2310 will be measured with imaging techniques to characterize plasma exposure levels versus regionally specific target engagement fractions for oral doses of BPN14770, an investigational new drug (IND) for modulating PDE4D. BPN14770 is under evaluation for the treatment of Fragile X syndrome and Alzheimer's disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: BPN14770, T2310Stage 1 safety assessments will be performed before and after the administration of a single, 185 MBq (5mCi) dose of T2310 in up to three healthy volunteers. Stage 2 will evaluate the relationship between plasma concentration of BPN14770, an investigational PDE4D modulator, and brain target occupancy in up to six healthy volunteers. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Willing and able to provide written informed consent.
- 2. Subjectively healthy
- 3. Between 18 and 75 years, inclusive, but preference will be given to subjects who are less than 55 years old.
- 4. The subject weighs at least 45 kg and has a body mass index between 18.0 and 32 kg/m2.
- 5. Subjects should be willing to observe the following contraception requirements from Screening until 90 days after the final follow-up visit: Male subjects must be willing to inform female partners of their participation in the study and must agree to use adequate contraceptive methods (vasectomy performed at least 6 months prior to dosing BPN14770 or use at least one barrier method of birth control). Female subjects: Female subjects must be surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to dosing of BPN14770), at least two years post-menopausal, or willing to use one barrier plus a hormonal contraceptive method of contraception from initial screening until one month after taking the last dose of study drug
Key exclusion criteria (16 listed)
- 1. Known history or evidence of a clinically significant medical condition, disorder, or disease that, in the opinion of the investigator, would pose a risk to subject safety, proper completion of the procedures, or the integrity of the study.
- 2. Clinical laboratory studies suggestive of a medically meaningful disease or condition that, in the opinion of the investigator, could pose a risk to subject safety, proper completion of the procedures, or the integrity of the study.
- 3. Contraindication to MRI based on the standard MRI screening questionnaire at CBIC. Contraindications include ferromagnetic foreign bodies (e.g., shrapnel, ferromagnetic sheet metal fragments in the orbital area), certain implanted medical devices (e.g., older aneurysm clips, cardiac pacemakers), or claustrophobia.
- 4. Unexpected findings on screening MRI that are indicative of an occult brain disease, or will potentially compromise subject safety or the scientific integrity of the study data.
- 5. Previous exposure to ionizing radiation for research purposes, such that, in combination with the exposure from this study, their exposure to research associated radiation will be >50 mSv/year for the previous year.
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 |
|---|---|---|
| BPN14770, T2310Subjects will be administered radio ligand T2310 and BPN14770 to determine brain occupancy of BPN14770. | Drug | Test Group |
Primary outcome
Adverse Events
Time frame: 1-8 Days
To assess the safety and tolerability of [11C]T2310 when administered alone and when co-administered with BPN14770
Plasma Concentration
Time frame: 24 Hours
To determine relationships between plasma concentrations of BPN14770 and the total volume of distribution of T2310 as a proxy for brain PDE4D occupancy by BPN14770 following single oral dosing regimens of BPN14770 over a 24 hour time
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
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.
Paul D Mozley, MD principal investigator
Weill Cornell College of Medicine
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 BPN14770, T2310 in people with To Determine Brain Target Occupancy of BPN14770, run by Tetra Discovery Partners 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 5 inclusion and 16 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: withdrawn, as of the sponsor's last update on 10 Jan 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Adverse Events (time frame: 1-8 Days). 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 10 Jan 2022.