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14C-JNJ-42847922

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: May 10, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03025022A Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-JNJ-42847922 After a Single Oral Dose of 40 mg in Healthy SubjectsPHASE1 COMPLETED 8Jan 17, 2017Feb 27, 2017May 10, 20171 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
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

The Cmax is the maximum observed plasma concentration.

Time to Reach Maximum Observed Plasma Concentration (Tmax)
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

The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

Time to Last Observed Quantifiable Concentration (T[last])
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

The T(last) is the time to last observed quantifiable concentration.

Area Under the Curve From Time Zero to End of Dosing Interval (AUC[last])
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

The AUC(last) is the measure of the plasma drug concentration from time zero to time of the last observed quantifiable concentration.

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
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

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.

Percent of AUC(0-infinity) Extrapolated (%AUC_extrap)
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

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.

Elimination Half-Life (t[1/2])
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

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).

Elimination Rate Constant (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

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.

Apparent Total Clearance (CL/F)
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

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.

Apparent Volume of Distribution (Vd/F)
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

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.

Amount of Drug Excreted in Urine (Ae)
Up to Day 14

Ae refers to the total amount of drug excreted in urine.

Percentage of Drug Excreted in Urine (%Ae)
Up to Day 14

The %Ae is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.

Renal Clearance (CLr)
Up to Day 14

The CLr is the renal clearance of the drug, calculated as Ae/AUC(0-infinity).

Amount of Drug Excreted in Feces (Fe)
Up to Day 14

The Fe refers to the total amount of drug excreted in feces.

Percentage of Drug Excreted in Feces (%Fe)
Up to Day 14

The %Fe is the total amount excreted in feces, expressed as a percentage of the administered dose.

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
From Screening to End of study (Approximately up to 46 days)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
14C-JNJ-42847922 40 miiligram (mg)EXPERIMENTALParticipants will receive a single 40 mg oral dose of 14C-JNJ-42847922 on Day 1.
Interventions
NameTypeDescription
14C-JNJ-42847922 40 mgDRUGParticipants 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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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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