Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
14C-JNJ-42847922 · 1 trial · 1 indication
The Cmax is the maximum observed plasma concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The T(last) is the time to last observed quantifiable concentration.
The AUC(last) is the measure of the plasma drug concentration from time zero to time of the last observed quantifiable concentration.
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.
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.
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).
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.
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.
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.
Ae refers to the total amount of drug excreted in urine.
The %Ae is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.
The CLr is the renal clearance of the drug, calculated as Ae/AUC(0-infinity).
The Fe refers to the total amount of drug excreted in feces.
The %Fe is the total amount excreted in feces, expressed as a percentage of the administered dose.
| Arm | Type | Description |
|---|---|---|
| 14C-JNJ-42847922 40 miiligram (mg) | EXPERIMENTAL | Participants will receive a single 40 mg oral dose of 14C-JNJ-42847922 on Day 1. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Signed an informed consent document indicating they (healthy participants) understand the purpose of and procedures required for the study and are willing to participate in the study * Willing to adhere to the prohibitions and restrictions specified in the protocol * Women may...
14C-JNJ-42847922 is a carbon-14 labeled small molecule developed by Johnson & Johnson for research use. It was studied in a Phase 1 clinical trial to investigate its absorption, distribution, metabolism, and excretion in healthy subjects. The radiolabeled version allows researchers to track how the drug moves through and is cleared from the body.
14C-JNJ-42847922 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound is part of the company's clinical research pipeline.
14C-JNJ-42847922 is in Phase 1 clinical development. The single trial conducted with this radiolabeled compound has been completed, and no active trials are currently listed. It remains an investigational agent and has not been approved by the FDA.
14C-JNJ-42847922 has been evaluated in one completed Phase 1 trial, NCT03025022. The study investigated the absorption, distribution, metabolism, and excretion of a single 40 mg oral dose in 8 healthy subjects in the United States. It was an open-label, uncontrolled study.