Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03089918 | A Study to Investigate the Regional Brain Kinetics of Brain Drug Transporters Using P-glycoprotein and Breast Cancer Resistance Protein Substrates and by Using the Positron Emission Tomography Ligand 11C-JNJ-63779586 in the Human Brain | PHASE1 | COMPLETED | 11 | — | — | May 17, 2017 | Aug 24, 2018 | Apr 27, 2025 | 2 | Belgium |
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...