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| ID | Type | Description | Link |
|---|---|---|---|
| 42847922EDI1008 | Other Identifier | Janssen Research & Development, LLC |
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The objective of this study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of 14C-JNJ-42847922 in healthy subjects after a single oral dose of 40 milligram (mg) 14C-JNJ-42847922 containing maximally 100 MicroCurie. Safety and tolerability will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C-JNJ-42847922 40 miiligram (mg) | Experimental | Participants will receive a single 40 mg oral dose of 14C-JNJ-42847922 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-JNJ-42847922 40 mg | Drug | Participants will receive a single 40 mg oral dose of 14C-JNJ-42847922 containing maximally 100 MicroCurie as a 40 milliLitre (mL) solution. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | The Cmax is the maximum observed plasma concentration. | Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose |
| Time to Last Observed Quantifiable Concentration (T[last]) | The T(last) is the time to last observed quantifiable concentration. | Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUC[last]) | The AUC(last) is the measure of the plasma drug concentration from time zero to time of the last observed quantifiable concentration. | Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) | The 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, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. | Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose |
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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 |
|---|---|---|---|---|---|---|
| Madison | Wisconsin | United States |
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| Percent of AUC(0-infinity) Extrapolated (%AUC_extrap) | The %AUC_extrap is the percentage of AUC(0-infinity) accounted for by extrapolation. It is calculated as (AUC [infinity] minus [-] AUC[last])*100/ AUC[infinity], where AUC[infinity] is area under the plasma concentration versus time curve from time zero to extrapolated infinite time and AUC(last) is area under the plasma concentration time-curve from zero to the last measured concentration. | Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose |
| Elimination Half-Life (t[1/2]) | The elimination half-life (t[1/2]) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose |
| Elimination Rate Constant (Lambda [z]) | Lambda(z) is first-order elimination 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. | Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose |
| Apparent Total Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose |
| Apparent Volume of Distribution (Vd/F) | 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 plasma concentration of a drug. Apparent volume of distribution after oral dose (Vd/F) is influenced by the fraction absorbed. | Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose |
| Amount of Drug Excreted in Urine (Ae) | Ae refers to the total amount of drug excreted in urine. | Up to Day 14 |
| Percentage of Drug Excreted in Urine (%Ae) | The %Ae is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100. | Up to Day 14 |
| Renal Clearance (CLr) | The CLr is the renal clearance of the drug, calculated as Ae/AUC(0-infinity). | Up to Day 14 |
| Amount of Drug Excreted in Feces (Fe) | The Fe refers to the total amount of drug excreted in feces. | Up to Day 14 |
| Percentage of Drug Excreted in Feces (%Fe) | The %Fe is the total amount excreted in feces, expressed as a percentage of the administered dose. | Up to Day 14 |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | From Screening to End of study (Approximately up to 46 days) |