Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 was studied in a Phase 1 trial in healthy male participants to evaluate how the drug is absorbed, metabolized, and excreted in the body.
14C-lazertinib is a radiolabeled version of lazertinib, which belongs to the -tinib kinase inhibitor class. The carbon-14 label allows researchers to track the drug and its metabolites through the body. The study was conducted in healthy volunteers rather than in patients with a specific disease.
Johnson & Johnson develops 14C-lazertinib. The compound is a carbon-14 labeled form of lazertinib, also known as JNJ-73841937. Johnson & Johnson trades on the New York Stock Exchange under the ticker JNJ.
14C-lazertinib has been studied in a Phase 1 clinical trial. It is an investigational compound and is not approved by the FDA. The single Phase 1 study has been completed, and no active trials are currently listed for this radiolabeled form.
14C-lazertinib was evaluated in one completed Phase 1 trial, NCT04410081, titled A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants. The trial enrolled 8 healthy male volunteers aged 18 years and older in the Netherlands. It was an uncontrolled study without randomization or blinding.
14C-lazertinib is a carbon-14 radiolabeled form of lazertinib, also known as JNJ-73841937. The two names refer to the same active molecule, with the 14C prefix indicating the radiolabel used in the Phase 1 study to trace the drug through the body.