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14C-lazertinib

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Mar 29, 2021

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
NCT04410081A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male ParticipantsPHASE1 COMPLETED 8Jul 14, 2020Mar 2, 2021Mar 29, 20211 Netherlands
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of 14C-lazertinib
Up to 99 days

Cmax is defined as maximum observed plasma concentration.

Time to Reach Maximum Observed Plasma Concentration (Tmax) of 14C-lazertinib
Up to 99 days

Tmax is defined time to reach the maximum observed concentration.

Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC [0-last]) of 14C-lazertinib
Up to 99 days

AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to the time of last observed quantifiable concentration.

Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of 14C-lazertinib
Up to 99 days

AUC (0-infinity) is defined as area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(0-last)+C(last)/ lambda(z), where C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

Elimination Half-life (t1/2) of 14C-lazertinib
Up to 99 days

Elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

Apparent Terminal Elimination Rate Constant (Lambda[z])
Up to 99 days

Lambda(z) is defined as apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration vs time data.

Total Apparent Clearance (CL/F) of 14C-lazertinib
Up to 99 days

Clearance is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as dose/AUC (0-infinity).

Apparent Volume of Distribution (Vdz/F) of 14C-lazertinib
Up to 99 days

Apparent volume of distribution, calculated as dose/(Lambda(z)\*AUC (0-infinity).

Ratio of Blood to Plasma Total Radioactivity of 14C-lazertinib
Up to 99 days

Blood to plasma total radioactivity ratio, calculated as blood total radioactivity/plasma total radioactivity.

Ratio of AUC (0-infinity) of 14C-lazertinib to AUC (0-infinity) of Total Radioactivity in Plasma
Up to 99 days

The ratio of AUC (0-infinity) of 14C-lazertinib to AUC (0-infinity) of total radioactivity in plasma will be assessed.

Ratio of AUC (0-last) of 14C-lazertinib Concentration to AUC (0-last) of Total Radioactivity in Plasma
Up to 99 days

The ratio of AUC (0-last) of 14C-lazertinib to AUC (0-last) of total radioactivity in plasma will be assessed.

Ratio of Cmax of 14C-lazertinib to Cmax of Total Radioactivity in Plasma
Up to 99 days

The ratio of Cmax of 14C-lazertinib to Cmax of total radioactivity in plasma will be assessed.

Ratio of 14C-lazertinib Concentration to Total Radioactivity in Plasma
Up to 99 days

The ratio of 14C-lazertinib concentration to total radioactivity in plasma for each sampling time point will be assessed.

Amount of 14C-lazertinib Excreted in Urine (Ae[t1-t2])
Up to 99 days

Amount excreted into the urine during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the urinary volume with the urinary concentration for that interval.

Cumulative Amount of 14C-lazertinib Excreted in Urine (Ae)
Up to 99 days

Cumulative amount excreted into the urine over the entire collection period, calculated as the sum of Ae's across the collection intervals for each participant.

Percentage of 14C-lazertinib Dose Excreted in Urine (%Ae)
Up to 99 days

Cumulative amount excreted into the urine, expressed as a percentage of the administered dose, calculated as (Ae divided by dose)\*100.

Renal Clearance (CLr) of 14C-lazertinib
Up to 99 days

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

Amount of 14C-lazertinib Excreted in Feces (Fe[t1-t2])
Up to 99 days

Amount excreted into the feces during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the feces weight with the feces concentration for that interval.

Cumulative Amount of 14C-lazertinib Excreted in Feces (Fe)
Up to 99 days

Cumulative amount excreted into the feces over the entire collection period, calculated as the sum of Fe's across the collection intervals for each participant.

Percentage of 14C-lazertinib Dose Excreted in Feces (%Fe)
Up to 99 days

Cumulative amount excreted into the feces, expressed as a percentage of the administered dose, calculated as (Fe divided by dose)\*100.

Total Recovery of 14C-lazertinib Dose in Feces and Urine
Up to 99 days

Total recovery, calculated as sum of %Ae and %Fe.

Secondary Endpoints
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to 135 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
14C-lazertinibEXPERIMENTALParticipants will receive a single oral dose of 14C-lazertinib on Day 1.
Interventions
NameTypeDescription
14C-lazertinibDRUGA single oral dose of 14C-lazertinib will be administered.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must be healthy on the basis of medical history performed at screening and physical examination and vital signs (pulse rate and body temperature) performed at screening and admission to the study site * Participants must be healthy on the basis of clinical laboratory tests per...

Countries:Netherlands
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