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| ID | Type | Description | Link |
|---|---|---|---|
| 64326067EDI1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to measure the whole-body distribution and radiation dosimetry of 18F-JNJ-64326067 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-JNJ-64326067 | Experimental | Participants will receive single intravenous (IV) bolus injection of 18F-JNJ-64326067 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-JNJ-64326067 | Drug | 18F-JNJ-64326067 will be administered intravenously between a dose of 185 Megabecquerel (MBq) to 370 MBq. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 36 days |
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Inclusion Criteria:
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:
(a) 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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Invicro | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| C000705448 | JNJ-64326067 |
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