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| ID | Type | Description | Link |
|---|---|---|---|
| 61393215EDI1001 | Other Identifier | Janssen-Cilag International NV | |
| 2016-000822-20 | EudraCT Number |
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The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 versus placebo after single oral dose administration under fasted (ascending dose levels) and fed condition, to characterize the pharmacokinetics of JNJ-61393125 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate the effect of food (high fat/high calorie) on the pharmacokinetics of JNJ-61393215 following single oral dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Cohort 1 | Experimental | Participants will receive 1 milligram (mg) JNJ-61393215 or placebo. |
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| Part 1: Cohort 2 | Experimental | Participants will receive 5 mg JNJ-61393215 or placebo. |
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| Part 1: Cohort 3 | Experimental | Participants will receive 15 mg JNJ-61393215 or placebo. |
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| Part 1: Cohort 4 | Experimental | Participants will receive 30 mg JNJ-61393215 or placebo. |
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| Part 1: Cohort 5 | Experimental | Participants will receive 45 mg JNJ-61393215 or placebo. |
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| Part 1: Cohort 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-61393215 | Drug | JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability | Up to follow-up phase (7 to 14 days after study drug administration) | |
| Maximum Plasma Concentration (Cmax) of JNJ-61393125 | The Cmax is the maximum observed plasma concentration. | Up to Day 4 |
| Last Quantifiable Plasma Concentration (Clast) of JNJ-61393125 | The Clast is the last quantifiable plasma concentration. | Up to Day 4 |
| Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-61393125 | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Up to Day 4 |
| Time of the Last Quantifiable Plasma Concentration (Tlast) of JNJ-61393125 | The Tlast is defined as the time of the last quantifiable plasma concentration. | Up to Day 4 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration of JNJ-61393125 | The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. | Up to Day 4 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-61393125 | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in NeuroCart test battery Score | Effects of JNJ-61393215 on alertness/sedation will be assessed by means of the NeuroCart test battery (including pharmaco-electroencephalogram [EEG], saccadic eye movements, smooth pursuit, adaptive tracking, body sway, Bond & Lader Visual Analogue Scale (VAS), Bowdle VAS, Swiss Narcolepsy Scale [SNS]). | Up to Day 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 |
|---|---|---|---|---|---|---|
| Leiden | Netherlands |
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Participants will receive 60 mg JNJ-61393215 or placebo.
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| Part 1: Cohort 7 | Experimental | Participants will receive 90 mg JNJ-61393215 or placebo. |
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| Part 1: Cohort 8 | Experimental | Participants will receive 120 mg JNJ-61393215 or placebo. |
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| Part 2 | Experimental | Participants will receive JNJ-61393215 (dose to be determined). |
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| Part 3 | Experimental | Participants will receive JNJ-61393125 (dose to be determined) or placebo under fed conditions. |
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| Placebo | Drug | Matching placebo will be administered. |
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| Up to Day 4 |
| First Order Rate Constant (Lambda[z]) of JNJ-61393125 | Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve. | Up to Day 4 |
| Elimination Half-life (t1/2) of JNJ-61393125 | Elimination half-life (t [1/2]) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z). | Up to Day 4 |
| Total Clearance (CL/F) of JNJ-61393125 | Total clearance of drug after extravascular administration, uncorrected for absolute bioavailability, calculated as: D/AUC infinity. | Up to Day 4 |
| Creatinine Clearance (CLcr) of JNJ-61393125 | Up to Day 4 |
| Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT Fatigue) | The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The total FACIT-Fatigue score ranges from 0 to 52, with a higher score indicating less fatigue. | Up to Day 2 |
| Visual Verbal Learning Test (VVLT) Score | Assessment of cognition will be done by Visual Verbal Learning Test (VVLT) which includes 30 words in three consecutive word trials and the participants will be assessed for Immediate Recall and Delayed Recognition. | Up to Day 2 |