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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003040-37 | EudraCT Number | ||
| 54175446EDI1005 | Other Identifier | Janssen Research & Development, LLC |
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The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and cerebrospinal fluid (CSF), the effects of JNJ-54175446 on markers of (neuro) inflammation/protection in blood and CSF and the pharmacokinetics of JNJ-54175446 followed by single and multiple dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Cohort A1 (JNJ-54175446 30 milligram[mg]) | Experimental | Healthy elderly participants will receive single dose of 30mg JNJ-54175446. |
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| Part 1: Cohort A1 (JNJ-54175446 100mg) | Experimental | Healthy elderly participants will receive single dose of 100mg JNJ-54175446. |
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| Part 1: Cohort A1 (JNJ-54175446 300mg) | Experimental | Healthy elderly participants will receive single dose of 300mg JNJ-54175446. |
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| Part 1: Cohort A1 (Placebo) | Experimental | Healthy elderly participants will receive single dose of placebo. |
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| Part 1: Cohort A2 (JNJ-54175446 D1 mg) | Experimental | Healthy elderly participants will receive an additional dose D1 mg [less than or equal to (<=) 600 mg] of JNJ-54175446, to be determined. |
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| Part 1: Cohort A3 (JNJ-54175446 D2 mg) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-54175446 | Drug | Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma | Part 1: Up to Day 2 | |
| The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Plasma | Part 2: Up to Day 8 | |
| The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Cerebrospinal Fluid (CSF) | Part 1: Up to Day 2 | |
| The Effects of JNJ-54175446 (Dose Response) on Levels of Aβ Fragments in Cerebrospinal Fluid (CSF) | Part 2: Up to Day 8 | |
| The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood | Part 1: Up to Day 2 | |
| The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in Blood | Part 2: Up to Day 8 | |
| The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in CSF | Part 1: Up to Day 2 | |
| The Effects of JNJ-54175446 (Dose Response) on Markers of (Neuro)Inflammation / Protection in CSF | Part 2: Up to Day 8 | |
| Maximum Observed Plasma Concentration (Cmax) After Single- and Multiple-Dose Administration | Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8 | |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Screening up to follow-up (in part 1 and part 2 [approximately up to 8 weeks]) |
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Inclusion Criteria:
Part 1 and 2 (Elderly Participants):
Part 1 (Young Participants):
- Healthy male participants between 18 and 45 years of age, inclusive
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 |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35774109 | Derived | Triana-Baltzer G, Timmers M, De Boer P, Schoene M, Furey M, Bleys C, Vrancken I, Slemmon R, Ceusters M, van Nueten L, Kolb H. Profiling classical neuropsychiatric biomarkers across biological fluids and following continuous lumbar puncture: A guide to sample type and time. Compr Psychoneuroendocrinol. 2022 Jan 15;10:100116. doi: 10.1016/j.cpnec.2022.100116. eCollection 2022 May. |
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| Experimental |
Healthy young participants will receive a single dose D2 mg (<= 600 mg) of JNJ-54175446, to be determined. |
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| Part 1: Cohort A3 (Placebo) | Experimental | Healthy young participants will receive a single dose of placebo. |
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| Part 2: Cohort B1 (JNJ-54175446 D3 mg) | Experimental | Healthy elderly participants will receive multiple dose levels D3 mg (<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1. |
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| Part 2: Cohort B1 (Placebo) | Experimental | Healthy elderly participants will receive placebo determined based on the results from Cohort A1. |
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| Part 2: Cohort B2 (JNJ-54175446 D4 mg) | Experimental | Healthy elderly participants will receive multiple dose levels D4 mg (<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1. |
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| Part 2: Cohort B2 (Placebo) | Experimental | Healthy elderly participants will receive placebo determined based on the results from Cohort A1 |
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| Part 2: Cohort B3 (JNJ-54175446 D5 mg) | Experimental | Healthy elderly participants will receive multiple dose levels D5 mg (<= 450 mg) of JNJ-54175446 determined based on the results from Cohort A1. |
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| Part 2: Cohort B3 (Placebo) | Experimental | Healthy elderly participants will receive placebo determined based on the results from Cohort A1 |
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| Placebo | Drug | Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2. |
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| Minimum Observed Plasma Concentration (Cmin)During Dosing Interval |
| Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8 |
| The Observed Plasma Concentration Just Prior to the Beginning or at the end of a Dosing Interval of any Dose Other Than the First Dose (Ctrough) | Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8 |
| Average Plasma Concentration at Steady State Over the Dosing Interval (Cavg) | Part 1: Day 1 - Day 2; Par 2: Day 1, Day 2 to 6, Day 7, Day 8 |
| Time to Reach the Maximum Plasma Concentration, After Single- and Multiple-Dose Administration (Tmax) | Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8 |
| Area Under The Concentration-Time Curve From 0 To t Hours Postdosing (AUCt) | Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8 |
| Area Under the Concentration-Time Curve From 0 to 24 Hours Postdosing (AUC24h) | Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8 |
| The Ratio of the Maximum Plasma Concentration (Peak) to Trough Observed Concentration (Peak/Trough Ratio) | Part 1: Day 1 - Day 2; Part 2: Day 1 to Day 8 |
| ID | Term |
|---|---|
| C000655225 | JNJ-54175446 |
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