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 radiolabeled form of the small molecule drug lazertinib, being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied to understand its pharmacokinetics and metabolism in the body.
14C-lazertinib is used in clinical research to study the absorption, distribution, metabolism, and excretion of lazertinib in healthy male participants. It is not intended for therapeutic use in patients, but rather as a research tool to characterize the drug's behavior in the body.
14C-lazertinib is being developed by Johnson & Johnson, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers.
14C-lazertinib is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 1 study has been completed, with results expected to inform further development of lazertinib.
14C-lazertinib has one completed Phase 1 clinical trial, identified by the National Clinical Trial number NCT04410081. The study, titled 'A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants,' was conducted in the Netherlands and enrolled 8 healthy male volunteers aged 18 years and older.
14C-lazertinib is a radiolabeled version of lazertinib, where the carbon-14 isotope is incorporated into the molecule. This labeling allows researchers to track the drug's movement and metabolism in the body. The therapeutic effects are expected to be the same as non-radiolabeled lazertinib, but the 14C form is used specifically for research purposes.