HealthyPhase 1NCT03693391
A Study to Investigate Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic Acid (AMPA Gamma 8) Receptor Occupancy of JNJ-64140284 With Newly Developed Transmembrane AMPA Receptor Regulatory Protein (TARP)-Gamma 8 Positron Emission Tomography (PET) [18F]JNJ-64511070 in Healthy Men
A Phase 1 study testing JNJ-64140284 and Fluorine-18 Labeled [18F]-JNJ-64511070 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to measure the blocking of [18F]JNJ-64511070 binding in the brain at the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination (tmax) of JNJ-64140284 and determine the exposure/receptor interaction… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-64140284 and Fluorine-18 Labeled [18F]-JNJ-64511070
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Oct 2018to 13 Mar 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive (Body Mass Index [BMI] = weight/height^2)
- Non-smoker (not smoked for 3 months prior to screening) or/and has not used nicotine -containing products (for example, nicotine patch) for 3 months prior to screening
- Is willing to allow the investigators to place an arterial catheter in the radial artery, is assessed via physical examination (Allen Test) to be a good candidate for arterial catheter placement
- Has no history or laboratory evidence of a coagulopathy. (for participants undergoing positron emission tomography [PET] scan only)
- During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, in addition to the highly effective method of contraception, a man a) who is sexually active with a woman of childbearing potential and has not had vasectomy must agree to use a condom and their female partner should also use oral contraception or user independent method such as intrauterine device (IUD) or hormonal implant for at least the same duration; b) who is sexually active with a woman who is pregnant, must use a condom; c) must agree not to donate sperm
Who cannot join
- Exposed to greater than (>)1 milliSievert (mSv) of ionizing radiation participating as a participant in research studies 12 months before the start of this study
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator are acceptable
- Clinically significant abnormal physical and neurological examination, vital signs or 12-lead electrocardiogram (ECG) at screening or admission
- History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, liver or renal disease or obstruction to urinary flow, infection, or any other condition that the Investigator considers significant should exclude the participant. History of epilepsy or fits or unexplained black-outs
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies unless the participant has been successfully treated for HCV or HIV. Successful treatment should be confirmed by a negative ribonucleic acid (RNA) test for the virus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Investigate the AMPAɣ8 Receptor Occupancy of JNJ-64140284 With the Newly Developed TARP-γ8 PET Tracer [18F]JNJ-64511070 in Healthy Men
The purpose of this study is to measure the blocking of [18F]JNJ-64511070 binding in the brain at the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination (tmax) of JNJ-64140284 and determine the exposure/receptor interaction of JNJ-64140284 in healthy male participants following single oral dose administration of JNJ-64140284.
- Conditions
- Healthy
- Being tested
- JNJ-64140284, Fluorine-18 Labeled [18F]-JNJ-64511070
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64140284Drug
Single dose of JNJ-64140284 up to 3 mg oral solution will be administered under fasted conditions.
Fluorine-18 Labeled [18F]-JNJ-64511070Drug
An intravenous (IV) bolus injection of 185 MegaBecquerel (MBq) [18F]JNJ-64511070 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: JNJ-64140284 | Experimental | Participants in cohort 1 will receive single oral dose of JNJ-64140284 at a starting dose of 0.5 milligram (mg) under fasted conditions. The dose levels of JNJ-64140284 will be escalated sequentially based on the decisions of an independent Data Review Committee (iDRC), the clinical team and the investigator. First 3 participants will also receive an intravenous (IV) bolus injection of [18F]JNJ-64511070 at a dose of 185 megaBecquerel (MBq). Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent positron emission tomography-computed tomography (PET-CT) scan. Receives: Drug: JNJ-64140284; Drug: Fluorine-18 Labeled [18F]-JNJ-64511070 |
| Cohort 2: JNJ-64140284 | Experimental | Participants in cohort 2 will receive next dose level of JNJ-64140284 based upon the data-review from the previous cohort and on the decisions of an iDRC, the clinical team and the investigator. At least 3 participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq. Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent PET-CT scan. Receives: Drug: JNJ-64140284; Drug: Fluorine-18 Labeled [18F]-JNJ-64511070 |
| Cohort 3: JNJ-64140284 | Experimental | Participants in cohort 3 will receive next dose level of JNJ-64140284 based upon the data-review from the previous cohort and on the decisions of an iDRC, the clinical team and the investigator. At least 3 participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq. Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent PET-CT scan. Receives: Drug: JNJ-64140284; Drug: Fluorine-18 Labeled [18F]-JNJ-64511070 |
| Cohort 4: JNJ-64140284 | Experimental | Participants in cohort 4 will receive next dose level of JNJ-64140284 based upon the data-review from the previous cohort and on the decisions of an iDRC, the clinical team and the investigator. At least 3 participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq. Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent PET-CT scan. Receives: Drug: JNJ-64140284; Drug: Fluorine-18 Labeled [18F]-JNJ-64511070 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and Regional Brain Compartmental Kinetics for Volume of Distribution (V[t]) of 18FJNJ-64511070
The distribution of [18F]JNJ-64511070 in brain will be measured by positron emission tomography (PET) scans obtained along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics and volume of distribution (V[t]) of [18F]JNJ-64511070.
Measured: Approximately up to 1 hour on Day 2
Percentage of Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA gamma 8) Receptor Occupancy
Percentage of AMPAgamma8 receptor occupancy will be assessed by measuring the blocking of fluorine-18 labeled[18F]JNJ-64511070 uptake in the human brain by JNJ-64140284 using [18F]JNJ-64511070 positron emission tomography-computed tomography (PET-CT) scan and a post JNJ-64140284 scan obtained around tmax (approximately up to 1 hour on Day 2).
Measured: Approximately up to 1 hour on Day 2
Secondary outcomes (2)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Approximately 6 weeks
Change from Baseline in Electroencephalogram (EEG) Power at Day 2
EEG power spectral activity in the alpha 1, alpha 2, beta 1, beta 2, delta, theta and gamma frequency bands will be estimated for the baseline EEG recording and will be compared to the EEG power spectral activity in the same frequency bands on Day 2.
Measured: Baseline and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start17 Oct 2018
- Primary completion2 Mar 2019
- Study completion13 Mar 2019
Why it stopped: stopped because of a business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693391
- Sponsor's protocol ID
- CR108508
- Other IDs
- 64140284EDI1003, 2018-002539-98, 2018
- Status last verified
- Apr 2025
- First submitted
- 1 Oct 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Investigate the AMPAɣ8 Receptor Occupancy of JNJ-64140284 With the Newly Developed TARP-γ8 PET Tracer [18F]JNJ-64511070 in Healthy Men
- ClinicalTrials.gov ID
- NCT03693391
- Acronym / sponsor ID
- CR108508
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: stopped because of a business decision
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 3 Oct 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.
The purpose of this study is to measure the blocking of [18F]JNJ-64511070 binding in the brain at the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination (tmax) of JNJ-64140284 and determine the exposure/receptor interaction of JNJ-64140284 in healthy male participants following single oral dose administration of JNJ-64140284.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: JNJ-64140284 | Experimental | Drug: JNJ-64140284, Drug: Fluorine-18 Labeled [18F]-JNJ-64511070Participants in cohort 1 will receive single oral dose of JNJ-64140284 at a starting dose of 0.5 milligram (mg) under fasted conditions. The dose levels of JNJ-64140284 will be escalated sequentially based on the decisions of an independent Data Review Committee (iDRC), the clinical team and the investigator. First 3 participants will also receive an intravenous (IV) bolus injection of [18F]JNJ-64511070 at a dose of 185 megaBecquerel (MBq). Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent positron emission tomography-computed tomography (PET-CT) scan. |
| Cohort 2: JNJ-64140284 | Experimental | Drug: JNJ-64140284, Drug: Fluorine-18 Labeled [18F]-JNJ-64511070Participants in cohort 2 will receive next dose level of JNJ-64140284 based upon the data-review from the previous cohort and on the decisions of an iDRC, the clinical team and the investigator. At least 3 participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq. Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent PET-CT scan. |
| Cohort 3: JNJ-64140284 | Experimental | Drug: JNJ-64140284, Drug: Fluorine-18 Labeled [18F]-JNJ-64511070Participants in cohort 3 will receive next dose level of JNJ-64140284 based upon the data-review from the previous cohort and on the decisions of an iDRC, the clinical team and the investigator. At least 3 participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq. Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent PET-CT scan. |
| Cohort 4: JNJ-64140284 | Experimental | Drug: JNJ-64140284, Drug: Fluorine-18 Labeled [18F]-JNJ-64511070Participants in cohort 4 will receive next dose level of JNJ-64140284 based upon the data-review from the previous cohort and on the decisions of an iDRC, the clinical team and the investigator. At least 3 participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq. Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent PET-CT scan. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive (Body Mass Index [BMI] = weight/height^2)
- Non-smoker (not smoked for 3 months prior to screening) or/and has not used nicotine -containing products (for example, nicotine patch) for 3 months prior to screening
- Is willing to allow the investigators to place an arterial catheter in the radial artery, is assessed via physical examination (Allen Test) to be a good candidate for arterial catheter placement
- Has no history or laboratory evidence of a coagulopathy. (for participants undergoing positron emission tomography [PET] scan only)
- During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, in addition to the highly effective method of contraception, a man a) who is sexually active with a woman of childbearing potential and has not had vasectomy must agree to use a condom and their female partner should also use oral contraception or user independent method such as intrauterine device (IUD) or hormonal implant for at least the same duration; b) who is sexually active with a woman who is pregnant, must use a condom; c) must agree not to donate sperm
Key exclusion criteria (5 listed)
- Exposed to greater than (>)1 milliSievert (mSv) of ionizing radiation participating as a participant in research studies 12 months before the start of this study
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator are acceptable
- Clinically significant abnormal physical and neurological examination, vital signs or 12-lead electrocardiogram (ECG) at screening or admission
- History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, liver or renal disease or obstruction to urinary flow, infection, or any other condition that the Investigator considers significant should exclude the participant. History of epilepsy or fits or unexplained black-outs
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies unless the participant has been successfully treated for HCV or HIV. Successful treatment should be confirmed by a negative ribonucleic acid (RNA) test for the virus
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 |
|---|---|---|
| JNJ-64140284Single dose of JNJ-64140284 up to 3 mg oral solution will be administered under fasted conditions. | Drug | Cohort 1: JNJ-64140284, Cohort 2: JNJ-64140284, Cohort 3: JNJ-64140284, Cohort 4: JNJ-64140284 |
| Fluorine-18 Labeled [18F]-JNJ-64511070An intravenous (IV) bolus injection of 185 MegaBecquerel (MBq) [18F]JNJ-64511070 will be administered. | Drug | Cohort 1: JNJ-64140284, Cohort 2: JNJ-64140284, Cohort 3: JNJ-64140284, Cohort 4: JNJ-64140284 |
Primary outcome
Total and Regional Brain Compartmental Kinetics for Volume of Distribution (V[t]) of 18FJNJ-64511070
Time frame: Approximately up to 1 hour on Day 2
The distribution of [18F]JNJ-64511070 in brain will be measured by positron emission tomography (PET) scans obtained along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics and volume of distribution (V[t]) of [18F]JNJ-64511070.
Percentage of Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA gamma 8) Receptor Occupancy
Time frame: Approximately up to 1 hour on Day 2
Percentage of AMPAgamma8 receptor occupancy will be assessed by measuring the blocking of fluorine-18 labeled[18F]JNJ-64511070 uptake in the human brain by JNJ-64140284 using [18F]JNJ-64511070 positron emission tomography-computed tomography (PET-CT) scan and a post JNJ-64140284 scan obtained around tmax (approximately up to 1 hour on Day 2).
2 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Approximately 6 weeks
Change from Baseline in Electroencephalogram (EEG) Power at Day 2
Time frame: Baseline and Day 2
Results and safety
The study was stopped early (reason given: stopped because of a business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 JNJ-64140284 and Fluorine-18 Labeled [18F]-JNJ-64511070 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 5 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: stopped early, as of the sponsor's last update on 27 Apr 2025. 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 Belgium. 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 stopped early (reason given: stopped because of a business decision). Results are not available in the source record.
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?
Total and Regional Brain Compartmental Kinetics for Volume of Distribution (V[t]) of 18FJNJ-64511070 (time frame: Approximately up to 1 hour on Day 2). 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 27 Apr 2025.