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| ID | Type | Description | Link |
|---|---|---|---|
| 64140284EDI1003 | Other Identifier | Janssen Research & Development, LLC | |
| 2018-002539-98 | EudraCT Number |
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stopped because of a business decision
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The purpose of this study is to measure the blocking of [18F]JNJ-64511070 binding in the brain at the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination (tmax) of JNJ-64140284 and determine the exposure/receptor interaction of JNJ-64140284 in healthy male participants following single oral dose administration of JNJ-64140284.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: JNJ-64140284 | Experimental | Participants in cohort 1 will receive single oral dose of JNJ-64140284 at a starting dose of 0.5 milligram (mg) under fasted conditions. The dose levels of JNJ-64140284 will be escalated sequentially based on the decisions of an independent Data Review Committee (iDRC), the clinical team and the investigator. First 3 participants will also receive an intravenous (IV) bolus injection of [18F]JNJ-64511070 at a dose of 185 megaBecquerel (MBq). Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent positron emission tomography-computed tomography (PET-CT) scan. |
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| Cohort 2: JNJ-64140284 | Experimental | Participants in cohort 2 will receive next dose level of JNJ-64140284 based upon the data-review from the previous cohort and on the decisions of an iDRC, the clinical team and the investigator. At least 3 participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq. Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent PET-CT scan. |
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| Cohort 3: JNJ-64140284 | Experimental | Participants in cohort 3 will receive next dose level of JNJ-64140284 based upon the data-review from the previous cohort and on the decisions of an iDRC, the clinical team and the investigator. At least 3 participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq. Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent PET-CT scan. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64140284 | Drug | Single dose of JNJ-64140284 up to 3 mg oral solution will be administered under fasted conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total and Regional Brain Compartmental Kinetics for Volume of Distribution (V[t]) of 18FJNJ-64511070 | The distribution of [18F]JNJ-64511070 in brain will be measured by positron emission tomography (PET) scans obtained along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics and volume of distribution (V[t]) of [18F]JNJ-64511070. | Approximately up to 1 hour on Day 2 |
| Percentage of Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA gamma 8) Receptor Occupancy | Percentage of AMPAgamma8 receptor occupancy will be assessed by measuring the blocking of fluorine-18 labeled[18F]JNJ-64511070 uptake in the human brain by JNJ-64140284 using [18F]JNJ-64511070 positron emission tomography-computed tomography (PET-CT) scan and a post JNJ-64140284 scan obtained around tmax (approximately up to 1 hour on Day 2). | Approximately up to 1 hour on Day 2 |
| 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. | Approximately 6 weeks |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
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| Cohort 4: JNJ-64140284 | Experimental | Participants in cohort 4 will receive next dose level of JNJ-64140284 based upon the data-review from the previous cohort and on the decisions of an iDRC, the clinical team and the investigator. At least 3 participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq. Participants with no measurable brain receptor occupancy will receive second (escalated) dosing with JNJ-64140284 and subsequent PET-CT scan. |
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| Fluorine-18 Labeled [18F]-JNJ-64511070 | Drug | An intravenous (IV) bolus injection of 185 MegaBecquerel (MBq) [18F]JNJ-64511070 will be administered. |
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| Change from Baseline in Electroencephalogram (EEG) Power at Day 2 | EEG power spectral activity in the alpha 1, alpha 2, beta 1, beta 2, delta, theta and gamma frequency bands will be estimated for the baseline EEG recording and will be compared to the EEG power spectral activity in the same frequency bands on Day 2. | Baseline and Day 2 |