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| ID | Type | Description | Link |
|---|---|---|---|
| 42847922EDI1005 | Other Identifier | Janssen Cilag N.V./S.A., Belgium | |
| 2014-005499-27 | EudraCT Number |
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The purpose of this study is to assess the effects of repeated once daily administration of 200 milligram (mg) of itraconazole (steady state) on the single-dose pharmacokinetics of JNJ 42847922 in healthy, male participants.
This is an open-label (all people know the identity of the intervention), fixed-sequence, single-center, single-dose study designed to assess the effects of steady-state itraconazole exposure on the pharmacokinetics of a single oral dose of JNJ 42847922 in healthy male participants. The duration of study will be approximately of 6 weeks per participant. The study consists of 3 parts: Screening (that is, 21 days before study commences on Day 1); Open-label Treatment (6 days); and Follow-up (7 to 14 days after last dose of study drug or early withdrawal).
All eligible participants will receive single oral doses of 5 milligram (mg) JNJ-42847922 on Day 1 and Day 6. A daily dose of 200 mg itraconazole will be administered from Day 2 to Day 6. Followed by an overnight fast of at least 8 hours participants will be administered with study treatment 30 minutes after light breakfast. Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-42847922 plus Itraconazole | Experimental | Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter [mL] oral solution on Day 1 and Day 6 and itraconazole as 200 mg (2*100 mg capsule) from Day 2 to Day 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42847922 | Drug | Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter [mL] oral solution on Day 1 and Day 6. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of JNJ-42847922 | The Cmax is the maximum plasma concentration. | up to Day 6 |
| Time to Reach Maximum Concentration (tmax) of JNJ-42847922 | The tmax is time to reach the maximum observed plasma concentration. | up to Day 6 |
| Time to Reach Last Quantifiable Plasma Concentration (tlast) of JNJ-42847922 | The tmax is time to last observed quantifiable plasma concentration. | up to Day 6 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-42847922 | The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. | up to Day 6 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-42847922 | 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(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant. | up to Day 6 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) of JNJ-42847922 | The AUC (0-24) is the area under the plasma concentration-time curve from time 0 to time 24 hours | up to Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was 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. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | Germany |
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| ID | Term |
|---|---|
| C000655226 | seltorexant |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Participants will receive single dose of itraconazole as 200 mg (2*100 mg capsule) from Day 2 to Day 6. |
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| Elimination Half-Life (t [1/2] Lambda) of JNJ-42847922 | Elimination half-life (t [1/2] Lambda) 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 6 |
| Rate Constant (Lambda[z]) | 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 6 |
| Apparent total body clearance (CL/F) of JNJ-42847922 | Clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The CL/F will be calculated by dividing the dose by AUC (0-infinity) | up to Day 6 |
| Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-42847922 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.The Vd(z)/F will be calculated by dividing CL/F by lambda(z). | up to Day 6 |
| Mean Residence Time of JNJ-42847922 | Mean residence time, calculated as area under the first moment curve (AUMC[0-infinity]/AUC(0-infinity). | up to Day 6 |
| Amount of JNJ-42847922 Excreted in Urine (Ae) | amount excreted into the urine, calculated by multiplying the urinary volume with the urinary concentration. | up to Day 6 |
| Percentage of JNJ-42847922 Dose Excreted in Urine | Amount excreted into the urine, expressed as a percentage of the administered dose, calculated as [Ae/dose]*100, and corrected for molecular weight when necessary. | up to Day 6 |
| Renal Clearance | Renal clearance calculated as Ae (total)/AUC (infinity). | up to Day 6 |
| up to End of study (7 to 14 days after lasr dose of study drug or early withdrawal) |
| D010879 |
| Piperazines |