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| ID | Type | Description | Link |
|---|---|---|---|
| 42847922EDI1003 | Other Identifier | Janssen-Cilag International NV | |
| 2014-000600-95 | EudraCT Number |
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The purpose of this study is to investigate the safety, tolerability, pharmacokinetic (the study of the way a drug enters and leaves the blood and tissues over time), dose-proportionality, accumulation, urinary excretion, pharmacodynamics (the study of how drugs act on the body) and sedative effects of JNJ-42847922 in healthy male and female participants.
This is a Phase 1, double blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug assigned by chance), placebo controlled, multiple ascending dose study. The study will consist of 3 parts: a Screening period (Days -21 to -2), a Double-blind treatment period (Day -1 to Day 11), and a Follow-up period (within 7 to 14 days after last dose administration). In double blind treatment period, participants will be randomly assigned to 5, 10, 20, and 40 milligram (mg) or placebo. Number of participants with any clinically relevant changes (adverse events [AEs], laboratory results,electrocardiogram [ECG], Vital signs, Physical and neurological, sedation & concentration) and columbia suicide severity rating (CSSR) scale will be evaluated as primary outcome measure. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-42847922, 5 milligram (mg) and Placebo | Experimental | Participants will be receive either 5 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10. |
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| JNJ-42847922, 10 mg and Placebo | Experimental | Participants will be receive either 10 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10. |
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| JNJ-42847922, 20 mg and Placebo | Experimental | Participants will be receive either 20 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10. |
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| JNJ-42847922, 40 mg and Placebo | Experimental | Participants will be receive either 40mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42847922 5 mg | Drug | Participants will receive 5 mg of JNJ-42847922, from Day 1 up to Day 10. |
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| Measure | Description | Time Frame |
|---|---|---|
| Supine and Standing Systolic and Diastolic Blood Pressure (BP) | BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Supine and Standing Heart Rate | Baseline up to End of study (7-14 days after last dose) or Early withdrawal | |
| Tympanic Temperature | Baseline up to End of study (7-14 days after last dose) or Early withdrawal | |
| 12 Lead Electrocardiogram (ECG): RR, QRS, PR, QT, QTcB, QTcF Interval | Baseline up to End of study (7-14 days after last dose) or Early withdrawal | |
| Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline up to End of study (7-14 days after last dose) or Early withdrawal | |
| Number of Participants with Adverse Events | Baseline up to End of study (7-14 days after last dose) or Early withdrawal | |
| Number of Participants With Change From Baseline in Laboratory Tests Results | Laboratory values included Hematology, clinical chemistry and urinalysis. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (C[max]) | The C(max) is the maximum plasma concentration which will be observed at the defined time points. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Time to Reach the Maximum Plasma Concentration (T[max]) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Sedation | Sedation will be assessed using a reaction time (RT) test battery, the Critical Flicker Fusion (CFF) test and body sway. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Bond and Lader Visual Analogue Scale (B and L VAS) |
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 |
|---|---|---|---|---|---|---|
| Berlin | Germany |
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| JNJ-42847922 10 mg | Drug | Participants will receive 10 mg of JNJ-42847922, from Day 1 up to Day 10. |
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| JNJ-42847922 20 mg | Drug | Participants will receive 20 mg of JNJ-42847922, from Day 1 up to Day 10. |
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| JNJ-42847922 40 mg | Drug | Participants will receive 40 mg of JNJ-42847922, from Day 1 up to Day 10 . |
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| Placebo | Drug | Participants will receive matching placebo from Day 1 up to Day 10. |
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| Physical and Neurological Examination | Physical and neurological examination will be performed. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
The T[max] is time to reach the observed maximum plasma concentration. |
| Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Time to Reach Last Quantifiable Plasma Concentration (T[last]) | The T[last] is time to reach the observed maximum plasma concentration. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Area Under the Plasma Concentration-Time Curve From Time Zero to hour 24 Time (AUC [0-24]) | AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours post-dose. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) | AUC (last) is the area under the plasma concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable concentration. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) | AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Average Plasma Concentration at Steady-State (C[avg]) | C(avg) is the average plasma concentration at steady state, calculated as AUC 0-24 divided by 24 | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Trough Plasma Concentration (C[trough]) | Trough plasma concentration is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Total Clearance (CL/F) | CL/F is the total clearance of drug after extravascular administration, uncorrected for absolute bioavailability. It is calculated as Dose divided by AUC. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Volume of Distribution (Vd/F) | Vd/F is the volume of distribution after extravascular administration, uncorrected for absolute bioavailability. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Elimination Half-life Period (t1/2) | Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda (z). | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Terminal slope (Lambda [z]) | Terminal slope is defined by 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. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Mean Residence Time (MRT) | MRT is the mean residence time calculated as area under the first moment curve at infinity (AUMC[0-∞]) divided by AUC[0-∞]. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Amount of Drug Excreted in Urine (Ae) | Ae is the amount of urine excreted in urine. It is calculated by multiplying the urinary volume with the urinary concentration. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Amount of Drug Excreted into Urine During the 24-hour Dosing Interval (Ae[0-24]) | Ae(0-24h) is the amount of drug excreted into urine during the 24-hour dosing interval. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Percentage of Drug Excreted in Urine (Ae%dose) | Ae%dose is the percentage of drug excreted into the urine calculated as (Ae divided by dose)∗100. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Renal Clearance (CL[R]) | CL(R) is the renal clearance of the drug, calculated as Ae/AUC[0-infinity] on Day 1 or Ae(0-24)/AUC(0-24) on Day 5 and Day 10. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
The B and L VAS includes 16 questions with VAS scales to rate subjective feelings. |
| Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| Addiction Research Center Inventory Questionnaire (ARCI-49) | The ARCI-49 item questionnaire is developed specifically to measure subjective effects of drugs with diverse pharmacological actions. | Baseline up to End of study (7-14 days after last dose) or Early withdrawal |
| ID | Term |
|---|---|
| C000655226 | seltorexant |
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