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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
Participants will receive a single 40 mg oral dose of 14C-JNJ-42847922 containing maximally 100 MicroCurie as a 40 milliLitre (mL) solution.
Unnamed facility
Madison, Wisconsin, United States
Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Percent of AUC(0-infinity) Extrapolated (%AUC_extrap)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 14
Renal Clearance (CLr)
The CLr is the renal clearance of the drug, calculated as Ae/AUC(0-infinity).
Time frame: Up to Day 14
Amount of Drug Excreted in Feces (Fe)
The Fe refers to the total amount of drug excreted in feces.
Time frame: 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.
Time frame: Up to Day 14
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: From Screening to End of study (Approximately up to 46 days)