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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003894-16 | EudraCT Number | ||
| 61393215EDI1002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 after multiple consecutive dose administrations and to characterize the pharmacokinetics (PK) of JNJ-61393215 in plasma after multiple consecutive dose administrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-61393215 (Multiple Ascending Dose Phase) | Experimental | Participants will receive JNJ- 61393215 once daily for 7 days. 4 sequential cohorts will be enrolled to evaluate escalating doses which will be defined, based on safety, tolerability and pharmacokinetic (PK) data from the preceding cohorts. Dose adjustment/selection (increase/decrease) for the next cohort will be based on the JNJ- 61393215 PK profile up to and including the last day of dosing (24 hours postdose) and the safety and tolerability profile of the current cohort. |
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| Placebo (Multiple Ascending Dose Phase) | Placebo Comparator | Participants will receive JNJ- 61393215 matching placebo for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-61393215 | Drug | Participants will receive JNJ-61393215 for 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability | up to 4 weeks | |
| Time To Reach The Maximum Plasma Concentration (Tmax) | Tmax is time to reach the maximum plasma concentration. | Day 1 |
| Maximum Plasma Concentration (Cmax) | Cmax is maximum plasma concentration. | Day 1 |
| Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24]) | AUC[0-24] is area under the plasma concentration- time curve from time [0 to 24]. | Day 1 |
| 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) | Ctrough is 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. | Days 2 to 6 |
| 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) | Ctrough is 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. | Day 7 |
| Minimum Observed Plasma Concentration During Dosing Interval (tau) (Cmin) | Cmin is minimum observed plasma concentration during dosing interval (tau). |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of JNJ-61393215 on Alertness/Sedation Through the Bond & Lader Visual Analogue Scale | Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end. The Bond-Lader of a 10 cm line. Participants will rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item is scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria are then calculated from the combined scores of selected items. The score ranges from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria. |
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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 |
|---|---|---|---|---|---|---|
| Leiden | Netherlands |
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| Placebo | Drug | Participants will receive JNJ- 61393215 matching placebo for 7 days. |
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| Day 7 |
| Time To Reach The Maximum Plasma Concentration (Tmax) | Tmax is time to reach the maximum plasma concentration. | Day 7 |
| Maximum Plasma Concentration (Cmax) | Cmax is maximum plasma concentration. | Day 7 |
| Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24]) | AUC[0-24] is Area under the plasma concentration- time curve from time [0 to 24]. | Day 7 |
| Average Plasma Concentration at Steady State Over the Dosing Interval (Cavg) | Cavg is average plasma concentration at steady state over the dosing interval. | Day 7 |
| Fluctuation Index (FI) | Fluctuation Index is defined as percentage of fluctuation, calculated as: 100*([Cmax-Cmin]/Cavg). | Day 7 |
| Total Apparent Oral Clearance, Calculated as Dose/AUCtau at Steady-State (CL/F) | CL/F is total apparent oral clearance, calculated as dose/AUCtau at steady-state. | Day 7 |
| Apparent Terminal Elimination Rate Constant, Determined By Linear Regression of the Terminal Points of the Ln-Linear Plasma Concentration-Time Curve (Lambda[Z]) | Lambda[Z] is apparent terminal elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve. | Day 7 |
| Apparent Elimination Half-Life Associated With The Terminal Slope of The Semilogarithmic Drug Concentration-Time Curve, After Multiple-Dose Administration Only (t1/2term) | T1/2term is apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, after multiple-dose administration only. | Day 7 |
| Ratio of Maximum Plasma Concentration (Cmax) Test (Day 7 [steady-state]/ref (Day 1) (Ratio Cmax,test/ref) | Ratio Cmax,test/ref is ratio of maximum plasma concentration (Cmax) test (day 7 [steady-state]/ref (day 1). | Day 7 |
| Ratio of Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24]) Test (Day 7 [steady-state]/ref (Day 1) (Ratio AUC24h,test/ref) | Ratio AUC24h,test/ref is ratio of area under the plasma concentration- time curve from time [0 to 24] (AUC[0-24]) test (day 7 [steady-state]/ref (day 1). | Day 7 |
| Day 1 and Day 7 |