Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-73841937
14C-lazertinib · 1 trial · 1 indication
Cmax is defined as maximum observed plasma concentration.
Tmax is defined time to reach the maximum observed concentration.
AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to the time of last observed quantifiable concentration.
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 associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
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.
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, calculated as dose/(Lambda(z)\*AUC (0-infinity).
Blood to plasma total radioactivity ratio, calculated as blood total radioactivity/plasma total radioactivity.
The ratio of AUC (0-infinity) of 14C-lazertinib to AUC (0-infinity) of total radioactivity in plasma will be assessed.
The ratio of AUC (0-last) of 14C-lazertinib to AUC (0-last) of total radioactivity in plasma will be assessed.
The ratio of Cmax of 14C-lazertinib to Cmax of total radioactivity in plasma will be assessed.
The ratio of 14C-lazertinib concentration to total radioactivity in plasma for each sampling time point will be assessed.
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 excreted into the urine over the entire collection period, calculated as the sum of Ae's across the collection intervals for each participant.
Cumulative amount excreted into the urine, expressed as a percentage of the administered dose, calculated as (Ae divided by dose)\*100.
The CLr is the renal clearance of the drug, calculated as Ae/AUC(0-infinity).
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 excreted into the feces over the entire collection period, calculated as the sum of Fe's across the collection intervals for each participant.
Cumulative amount excreted into the feces, expressed as a percentage of the administered dose, calculated as (Fe divided by dose)\*100.
Total recovery, calculated as sum of %Ae and %Fe.
| Arm | Type | Description |
|---|---|---|
| 14C-lazertinib | EXPERIMENTAL | Participants will receive a single oral dose of 14C-lazertinib on Day 1. |
| Name | Type | Description |
|---|---|---|
| 14C-lazertinib | DRUG | A single oral dose of 14C-lazertinib will be administered. |
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...
14C-lazertinib is a carbon-14 radiolabeled form of lazertinib, a small molecule kinase inhibitor developed by Johnson & Johnson. It is used in clinical research to study how the drug is absorbed, distributed, metabolized, and excreted in the body. The radiolabel allows researchers to track the drug and its metabolites.
14C-lazertinib targets kinases, as it is a kinase inhibitor. The carbon-14 label does not change the targeting; it is a radioactive tracer used to follow the drug's pharmacokinetics. The active moiety, lazertinib, is designed to inhibit kinase activity.
14C-lazertinib is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ. Johnson & Johnson is the sponsor of the clinical study involving this radiolabeled compound.
14C-lazertinib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 study has been completed.
14C-lazertinib has been studied in one clinical trial: NCT04410081, titled "A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants." This Phase 1 trial was completed and enrolled 8 healthy male participants in the Netherlands.
14C-lazertinib is a radiolabeled version of lazertinib, also known as JNJ-73841937. The "14C" indicates that the molecule contains carbon-14, which is used as a tracer in clinical pharmacology studies. The underlying active drug is lazertinib.