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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004517-55 | EudraCT Number | ||
| 55308942EDI1002 | Other Identifier | Janssen-Cilag International NV |
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The purpose of this study is to measure the blocking of [18F]-JNJ-64413739 uptake in the brain at the time to reach maximum plasma concentration (Tmax) and at 24 hours postdose of JNJ-55308942 following a single dose of JNJ-55308942; and to model the exposure/receptor interaction of JNJ-55308942.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: JNJ-55308942 and [18F]-JNJ-64413739 | Experimental | Participants will first undergo a baseline positron emission tomography (PET)/ magnetic resonance (MR) scan with [18F]-JNJ-64413739 on Day 1. In Period 1 (on Day 2) and Period 2 (on Day 1), participants will receive oral dose of JNJ-55308942 (maximum dose 120 milligram [mg]). After approximately 4 hours of JNJ-55308942 dosing, participants will receive an intravenous (IV) injection of [18F]-JNJ-64413739, followed by a PET/MR scan. Doses will be selected based on the principal investigator's discretion. A wash-out period of at least 7 days will be maintained between the 2 doses of JNJ-55308942. |
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| Part 2: JNJ-55308942 and [18F]-JNJ-64413739 | Experimental | Participants will first undergo a baseline PET/MR scan with [18F]-JNJ-64413739 on Day 1. Participants will receive oral dose of JNJ-55308942 (maximum dose 120 mg) on Day 2, followed by two post-treatment scans, one obtained at Tmax (4 hours postdose) and one at 24 hours postdose. Doses will be selected based on the principal investigator's discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-55308942 | Drug | JNJ-55308942 will be administered as oral solution. |
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| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and Part 2: Percentage of P2X7 Receptor Occupancy | [18F]-JNJ-64413739 uptake in brain following a single dose of JNJ-55308942 at Tmax of JNJ-55308942 will be measured using PET scans obtained at pre and post treatment with [18F]-JNJ-64413739, to determine the receptor occupancy. | 4 hours postdose (Tmax) |
| Part 2: Percentage of P2X7 Receptor Occupancy | [18F]-JNJ-64413739 uptake in brain following a single dose of JNJ-55308942 at 24 hours postdose will be measured using PET scans obtained at pre and post treatment with [18F]-JNJ-64413739, to determine the receptor occupancy. | 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and 2: 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 7 weeks (Part 1) and approximately 6 weeks (Part 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| C000630474 | JNJ-55308942 |
| C000706135 | (18)F-JNJ-64413739 |
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| [18F]-JNJ-64413739 | Drug | [18F]-JNJ-64413739 fluid for injection administered intravenously. |
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