HealthyPhase 1NCT03581916
A Study to Investigate the Whole Body Distribution and Radiation Dosimetry of the Positron Emission Tomography Ligand Fluoride-18 (18F)-JNJ-64326067 in Healthy Participants
A Phase 1 study testing 18F-JNJ-64326067 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to measure the whole-body distribution and radiation dosimetry of 18F-JNJ-64326067 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 18F-JNJ-64326067
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2018to 2 Nov 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Otherwise healthy for their age group on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening or Day 1 predose. If there are abnormalities, they must be consistent with the age of the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
- Otherwise healthy for their age group on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Women must be postmenopausal (must be documented by medical records or physician's note). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level at screening (greater than [>] 40 International Units Per Liter/ milli International Units Per milliLiter [IU/L) or mIU/mL]) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient
- During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, a man:
- who is sexually active with a woman of childbearing potential and has not had vasectomy must agree to use a barrier method of contraception (that is, condom). In addition, their female partner should also use a highly effective method of birth control (example, hormonal contraception) 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
- Willing and able to adhere to the prohibitions and restrictions specified for this clinical study
Who cannot join
- Radiation exposure through prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 milli sievert (mSv), which would be above the acceptable annual limits established by the United State (US) Federal Guidelines
- History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, epilepsy or fits or unexplained black outs, or any other illness that the Investigator considers should exclude the participant
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCV) or human immunodeficiency virus (HIV) antibodies at screening
- History of drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 6 months before screening or positive test result(s) for alcohol and/or drugs of abuse (opiates (including methadone), cocaine, amphetamines, cannabinoids, barbiturates, 3,4-methylenedioxy-methamphetamine (MDMA) and benzodiazepines) at screening or admission
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with written concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Investigate the Total Body Distribution and Radiation Dosimetry of the Positron Emission Tomography Ligand 18F-JNJ-64326067 in Healthy Subjects
The purpose of this study is to measure the whole-body distribution and radiation dosimetry of 18F-JNJ-64326067 in healthy participants.
- Conditions
- Healthy
- Being tested
- 18F-JNJ-64326067
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-JNJ-64326067Drug
18F-JNJ-64326067 will be administered intravenously between a dose of 185 Megabecquerel (MBq) to 370 MBq.
| Study group | Role | What they receive |
|---|---|---|
| 18F-JNJ-64326067 | Experimental | Participants will receive single intravenous (IV) bolus injection of 18F-JNJ-64326067 on Day 1. Receives: Drug: 18F-JNJ-64326067 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Radiation Dose Following Injection of 18F-JNJ-64326067 per Organ
The Effective Dose (ED) per organ will be calculated using Organ Level Internal Dose Assessment (OLINDA) software. After injection of 370 megaBecquerel (MBq) of 18F-JNJ-64326067, a series of whole-body positron emission tomography (PET) images will be obtained over a period of up to 6 hours and corrected for attenuation by computed tomography (CT) transmission scans using PET/CT. The unit of radioactivity will be milli Sieverts per mega Becquerel (mSv/MBq) for each organ and the effective dose per participant. The final values will be averaged across the participants.
Measured: Day 1
Effective Radiation Dose Following Injection of 18F-JNJ-64326067 for Whole Body
The ED for whole body will be calculated using OLINDA software. After injection of 370 MBq of 18F-JNJ-64326067, a series of whole-body PET images will be obtained over a period of up to 6 hours and corrected for attenuation by CT transmission scans using PET/CT. The unit of radioactivity will be mSv/MBq for the whole body and the effective dose per participant. The final values will be averaged across the participants.
Measured: Day 1
Secondary outcomes (1)
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: Up to 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start11 Jul 2018
- Primary completion2 Nov 2018
- Study completion2 Nov 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT03581916
- Sponsor's protocol ID
- CR108426
- Other IDs
- 64326067EDI1001
- Status last verified
- Apr 2025
- First submitted
- 27 Jun 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 Total Body Distribution and Radiation Dosimetry of the Positron Emission Tomography Ligand 18F-JNJ-64326067 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03581916
- Acronym / sponsor ID
- CR108426
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 10 Jul 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 whole-body distribution and radiation dosimetry of 18F-JNJ-64326067 in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-JNJ-64326067 | Experimental | Drug: 18F-JNJ-64326067Participants will receive single intravenous (IV) bolus injection of 18F-JNJ-64326067 on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Otherwise healthy for their age group on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening or Day 1 predose. If there are abnormalities, they must be consistent with the age of the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
- Otherwise healthy for their age group on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Women must be postmenopausal (must be documented by medical records or physician's note). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level at screening (greater than [>] 40 International Units Per Liter/ milli International Units Per milliLiter [IU/L) or mIU/mL]) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient
- During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, a man:
- Willing and able to adhere to the prohibitions and restrictions specified for this clinical study
Key exclusion criteria (5 listed)
- Radiation exposure through prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 milli sievert (mSv), which would be above the acceptable annual limits established by the United State (US) Federal Guidelines
- History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, epilepsy or fits or unexplained black outs, or any other illness that the Investigator considers should exclude the participant
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCV) or human immunodeficiency virus (HIV) antibodies at screening
- History of drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 6 months before screening or positive test result(s) for alcohol and/or drugs of abuse (opiates (including methadone), cocaine, amphetamines, cannabinoids, barbiturates, 3,4-methylenedioxy-methamphetamine (MDMA) and benzodiazepines) at screening or admission
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with written concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
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 |
|---|---|---|
| 18F-JNJ-6432606718F-JNJ-64326067 will be administered intravenously between a dose of 185 Megabecquerel (MBq) to 370 MBq. | Drug | 18F-JNJ-64326067 |
Primary outcome
Effective Radiation Dose Following Injection of 18F-JNJ-64326067 per Organ
Time frame: Day 1
The Effective Dose (ED) per organ will be calculated using Organ Level Internal Dose Assessment (OLINDA) software. After injection of 370 megaBecquerel (MBq) of 18F-JNJ-64326067, a series of whole-body positron emission tomography (PET) images will be obtained over a period of up to 6 hours and corrected for attenuation by computed tomography (CT) transmission scans using PET/CT. The unit of radioactivity will be milli Sieverts per mega Becquerel (mSv/MBq) for each organ and the effective dose per participant. The final values will be averaged across the participants.
Effective Radiation Dose Following Injection of 18F-JNJ-64326067 for Whole Body
Time frame: Day 1
The ED for whole body will be calculated using OLINDA software. After injection of 370 MBq of 18F-JNJ-64326067, a series of whole-body PET images will be obtained over a period of up to 6 hours and corrected for attenuation by CT transmission scans using PET/CT. The unit of radioactivity will be mSv/MBq for the whole body and the effective dose per participant. The final values will be averaged across the participants.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 36 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 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 18F-JNJ-64326067 in people with Healthy, run by Janssen Research & Development, LLC 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 6 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 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?
Effective Radiation Dose Following Injection of 18F-JNJ-64326067 per Organ (time frame: Day 1). 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.