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...
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11C-JNJ-63779586 is an investigational small molecule being studied for use in Alzheimer Disease. It is a positron emission tomography (PET) ligand intended to investigate regional brain kinetics of drug transporters in the human brain. The drug is in Phase 1 clinical development and is not yet approved.
11C-JNJ-63779586 is a PET ligand used to study P-glycoprotein and breast cancer resistance protein, which are brain drug transporters. It is designed to investigate the regional brain kinetics of these transporters in the human brain, particularly in the context of Alzheimer Disease.
11C-JNJ-63779586 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development for Alzheimer Disease.
11C-JNJ-63779586 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, with a total of 11 participants enrolled.
11C-JNJ-63779586 has one completed clinical trial, registered under NCT03089918. The study investigated regional brain kinetics of drug transporters using P-glycoprotein and breast cancer resistance protein substrates and the PET ligand 11C-JNJ-63779586 in the human brain. The trial was conducted in Belgium and enrolled 11 participants.
11C-JNJ-63779586 is a radiolabeled form of the compound JNJ-63779586, where the 11C isotope is used for positron emission tomography imaging. The drug is being studied as a PET ligand to investigate brain drug transporters in Alzheimer Disease.