Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
11C-JNJ-63779586 · 1 trial · 1 indication
Whole body and organ specific dosimetry for the tracer will be estimated using specific software for calculation of the absorbed radiation dose. Afterwards, dosimetry will be compared with other carbon-11 labeled radiotracers. According to these results, the same or lower dose might be used for Part B, to prevent high radiation doses to certain organs.
Regional brain uptake will be determined using a Volume of interest (VOI) based analysis. Differences in regional brain uptake between Alzheimer Disease (AD) and control participants will be determined using statistical parametric mapping. Regional uptake of 11C-JNJ-63779586 into brain (K1) will be assessed and compared between participants with AD and control participants, corrected for regional blood flow.
Sequential arterial blood samples will be taken post tracer injection to model an arterial input function (IF) of the tracer and allow analysis of radio metabolites (percent intact tracer).
Sequential arterial blood samples will be taken post tracer injection to model an arterial input function (IF) of the tracer and allow analysis of radio metabolites (percent intact tracer).
| Arm | Type | Description |
|---|---|---|
| Part A (Healthy Adult Male Participants) | EXPERIMENTAL | Participants will receive intravenous (IV) injection with 370 megabecquerel (MBq) 11C-JNJ-63779586 on Day 1 of Part A. |
| Part B (Mild AD and Healthy age- and Gender-Matched Controls) | EXPERIMENTAL | Participants will receive single IV injection of 11C-JNJ-63779586 on Day 1 of Part B followed by saline flush. During Part B, the dose may be reduced based on whole body dosimetric findings and image quality seen in Part A. |
| Name | Type | Description |
|---|---|---|
| 11C-JNJ-63779586 | DRUG | Participants will receive IV injection with 11C-JNJ-63779586 in Part A and Part B. |
Inclusion Criteria: Part A * Healthy men between 18 and 55 years of age, inclusive * Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) ², inclusive, and a body weight of not less than 50 kilogram (kg) Part B * Men or women with mild Alzheimer's Disease (AD), age- and gend...
Top 20 of 30 competitors
11C-JNJ-63779586 is a carbon-11 labeled small molecule developed by Johnson & Johnson as a positron emission tomography (PET) ligand. It is designed for imaging brain drug transporters in the human brain, specifically to study the regional brain kinetics of P-glycoprotein and breast cancer resistance protein substrates. It is an investigational research agent, not a therapeutic treatment.
11C-JNJ-63779586 is used as a PET imaging ligand to study brain drug transporter activity, including P-glycoprotein and breast cancer resistance protein, in Alzheimer disease research. It is not a treatment for Alzheimer disease. The completed Phase 1 study NCT03089918 evaluated its regional brain kinetics in human participants, including healthy volunteers, in Belgium.
11C-JNJ-63779586 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound is an investigational PET imaging ligand studied in neurology research, specifically for evaluating brain drug transporter kinetics in the context of Alzheimer disease.
11C-JNJ-63779586 is in Phase 1 development. It is an investigational agent and has not been approved by the FDA. One Phase 1 trial, NCT03089918, has been completed, and no trials are currently active. The study enrolled 11 participants and was conducted in Belgium.
11C-JNJ-63779586 has been evaluated in one completed Phase 1 clinical trial, NCT03089918, titled a study to investigate the regional brain kinetics of brain drug transporters using P-glycoprotein and breast cancer resistance protein substrates and the PET ligand 11C-JNJ-63779586 in the human brain. The trial enrolled 11 participants in Belgium, including healthy volunteers, and used a controlled design.