HealthyPhase 1NCT03437590
A Positron Emission Tomography (PET) Study to Investigate P2X7 Receptor Occupancy by JNJ-55308942 Using [18F]-JNJ-64413739
A Phase 1 study testing JNJ-55308942 and [18F]-JNJ-64413739 in people with Healthy, run by Janssen-Cilag International NV at 1 site in Belgium.
Trial summary
The purpose of this study is to measure the blocking of [18F]-JNJ-64413739 uptake in the brain at the time to reach maximum plasma concentration (Tmax) and at 24 hours postdose of JNJ-55308942 following a single dose of JNJ-55308942; and to model the exposure/receptor interaction of JNJ-55308942. 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-55308942 and [18F]-JNJ-64413739
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Mar 2018to 19 Oct 2018
- 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 (BMI = weight/height^2)
- 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 and should not be allergic to local anesthetics for catheter placement
- During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug participants must agree not to donate sperm. If a participant is sexually active with a woman he should agree to the following: (a) If it concerns a woman of childbearing potential and the participant has not had a vasectomy, the participant must agree to use a condom and make sure his female partner is using a highly effective method of birth control during the study and for a minimum of 90 days after the last dose of study drug. (b) If it concerns a woman of nonchild bearing potential, who is pregnant or has been sterilized and the participant has not had a vasectomy, the participant must agree to use a condom for the given period. (c) If the participant has had a vasectomy, he should agree to use a condom when being sexually active with a woman of child bearing potential. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
- Participants must have signed an informed consent document indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions
Who cannot join
- Exposed to greater than (>) 1 millisievert (mSv) of ionizing radiation participating as a participant in research studies in the 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 Principal 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, coagulation abnormalities, or other conditions that the Investigator considers should exclude the participant and preclude their ability to participate in study procedures. Participants with a history significant liver or renal disease, or difficulty in urination, which could affect the metabolism and elimination of the radiotracer or radiometabolites should be excluded. Participants with a history of epilepsy or fits or unexplained black-outs or loss of consciousness should also be excluded
- Participant has a QT corrected according to Fridericia's formula (QTcF) interval of >450 millisecond (msec) at Screening or prior to "baseline" on Day 1, or has a history of additional risk factors for torsades de pointes (example, heart failure, hypokalemia, family history of Long QT Syndrome)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label PET Study to Investigate P2X7 Receptor Occupancy by JNJ-55308942 Using [18F]-JNJ-64413739
The purpose of this study is to measure the blocking of [18F]-JNJ-64413739 uptake in the brain at the time to reach maximum plasma concentration (Tmax) and at 24 hours postdose of JNJ-55308942 following a single dose of JNJ-55308942; and to model the exposure/receptor interaction of JNJ-55308942.
- Conditions
- Healthy
- Being tested
- JNJ-55308942, [18F]-JNJ-64413739
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-55308942Drug
JNJ-55308942 will be administered as oral solution.
[18F]-JNJ-64413739Drug
[18F]-JNJ-64413739 fluid for injection administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: JNJ-55308942 and [18F]-JNJ-64413739 | Experimental | Participants will first undergo a baseline positron emission tomography (PET)/ magnetic resonance (MR) scan with [18F]-JNJ-64413739 on Day 1. In Period 1 (on Day 2) and Period 2 (on Day 1), participants will receive oral dose of JNJ-55308942 (maximum dose 120 milligram [mg]). After approximately 4 hours of JNJ-55308942 dosing, participants will receive an intravenous (IV) injection of [18F]-JNJ-64413739, followed by a PET/MR scan. Doses will be selected based on the principal investigator's discretion. A wash-out period of at least 7 days will be maintained between the 2 doses of JNJ-55308942. Receives: Drug: JNJ-55308942; Drug: [18F]-JNJ-64413739 |
| Part 2: JNJ-55308942 and [18F]-JNJ-64413739 | Experimental | Participants will first undergo a baseline PET/MR scan with [18F]-JNJ-64413739 on Day 1. Participants will receive oral dose of JNJ-55308942 (maximum dose 120 mg) on Day 2, followed by two post-treatment scans, one obtained at Tmax (4 hours postdose) and one at 24 hours postdose. Doses will be selected based on the principal investigator's discretion. Receives: Drug: JNJ-55308942; Drug: [18F]-JNJ-64413739 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 and Part 2: Percentage of P2X7 Receptor Occupancy
[18F]-JNJ-64413739 uptake in brain following a single dose of JNJ-55308942 at Tmax of JNJ-55308942 will be measured using PET scans obtained at pre and post treatment with [18F]-JNJ-64413739, to determine the receptor occupancy.
Measured: 4 hours postdose (Tmax)
Part 2: Percentage of P2X7 Receptor Occupancy
[18F]-JNJ-64413739 uptake in brain following a single dose of JNJ-55308942 at 24 hours postdose will be measured using PET scans obtained at pre and post treatment with [18F]-JNJ-64413739, to determine the receptor occupancy.
Measured: 24 hours postdose
Secondary outcomes (1)
Part 1 and 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 7 weeks (Part 1) and approximately 6 weeks (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start15 Mar 2018
- Primary completion19 Oct 2018
- Study completion19 Oct 2018
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437590
- Sponsor's protocol ID
- CR108439
- Other IDs
- 2017-004517-55, 55308942EDI1002, 2017
- Status last verified
- Apr 2025
- First submitted
- 13 Feb 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 PET Study to Investigate P2X7 Receptor Occupancy by JNJ-55308942 Using [18F]-JNJ-64413739
- ClinicalTrials.gov ID
- NCT03437590
- Acronym / sponsor ID
- CR108439
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 19 Feb 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-64413739 uptake in the brain at the time to reach maximum plasma concentration (Tmax) and at 24 hours postdose of JNJ-55308942 following a single dose of JNJ-55308942; and to model the exposure/receptor interaction of JNJ-55308942.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: JNJ-55308942 and [18F]-JNJ-64413739 | Experimental | Drug: JNJ-55308942, Drug: [18F]-JNJ-64413739Participants will first undergo a baseline positron emission tomography (PET)/ magnetic resonance (MR) scan with [18F]-JNJ-64413739 on Day 1. In Period 1 (on Day 2) and Period 2 (on Day 1), participants will receive oral dose of JNJ-55308942 (maximum dose 120 milligram [mg]). After approximately 4 hours of JNJ-55308942 dosing, participants will receive an intravenous (IV) injection of [18F]-JNJ-64413739, followed by a PET/MR scan. Doses will be selected based on the principal investigator's discretion. A wash-out period of at least 7 days will be maintained between the 2 doses of JNJ-55308942. |
| Part 2: JNJ-55308942 and [18F]-JNJ-64413739 | Experimental | Drug: JNJ-55308942, Drug: [18F]-JNJ-64413739Participants will first undergo a baseline PET/MR scan with [18F]-JNJ-64413739 on Day 1. Participants will receive oral dose of JNJ-55308942 (maximum dose 120 mg) on Day 2, followed by two post-treatment scans, one obtained at Tmax (4 hours postdose) and one at 24 hours postdose. Doses will be selected based on the principal investigator's discretion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive (BMI = weight/height^2)
- 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 and should not be allergic to local anesthetics for catheter placement
- During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug participants must agree not to donate sperm. If a participant is sexually active with a woman he should agree to the following: (a) If it concerns a woman of childbearing potential and the participant has not had a vasectomy, the participant must agree to use a condom and make sure his female partner is using a highly effective method of birth control during the study and for a minimum of 90 days after the last dose of study drug. (b) If it concerns a woman of nonchild bearing potential, who is pregnant or has been sterilized and the participant has not had a vasectomy, the participant must agree to use a condom for the given period. (c) If the participant has had a vasectomy, he should agree to use a condom when being sexually active with a woman of child bearing potential. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
- Participants must have signed an informed consent document indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions
Key exclusion criteria (5 listed)
- Exposed to greater than (>) 1 millisievert (mSv) of ionizing radiation participating as a participant in research studies in the 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 Principal 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, coagulation abnormalities, or other conditions that the Investigator considers should exclude the participant and preclude their ability to participate in study procedures. Participants with a history significant liver or renal disease, or difficulty in urination, which could affect the metabolism and elimination of the radiotracer or radiometabolites should be excluded. Participants with a history of epilepsy or fits or unexplained black-outs or loss of consciousness should also be excluded
- Participant has a QT corrected according to Fridericia's formula (QTcF) interval of >450 millisecond (msec) at Screening or prior to "baseline" on Day 1, or has a history of additional risk factors for torsades de pointes (example, heart failure, hypokalemia, family history of Long QT Syndrome)
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-55308942JNJ-55308942 will be administered as oral solution. | Drug | Part 1: JNJ-55308942 and [18F]-JNJ-64413739, Part 2: JNJ-55308942 and [18F]-JNJ-64413739 |
| [18F]-JNJ-64413739[18F]-JNJ-64413739 fluid for injection administered intravenously. | Drug | Part 1: JNJ-55308942 and [18F]-JNJ-64413739, Part 2: JNJ-55308942 and [18F]-JNJ-64413739 |
Primary outcome
Parts 1 and Part 2: Percentage of P2X7 Receptor Occupancy
Time frame: 4 hours postdose (Tmax)
[18F]-JNJ-64413739 uptake in brain following a single dose of JNJ-55308942 at Tmax of JNJ-55308942 will be measured using PET scans obtained at pre and post treatment with [18F]-JNJ-64413739, to determine the receptor occupancy.
Part 2: Percentage of P2X7 Receptor Occupancy
Time frame: 24 hours postdose
[18F]-JNJ-64413739 uptake in brain following a single dose of JNJ-55308942 at 24 hours postdose will be measured using PET scans obtained at pre and post treatment with [18F]-JNJ-64413739, to determine the receptor occupancy.
1 secondary outcome
Part 1 and 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Approximately 7 weeks (Part 1) and approximately 6 weeks (Part 2)
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 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-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
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-55308942 and [18F]-JNJ-64413739 in people with Healthy, run by Janssen-Cilag International NV 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 4 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: finished, 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 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?
Parts 1 and Part 2: Percentage of P2X7 Receptor Occupancy (time frame: 4 hours postdose (Tmax)). 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.