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14C-lazertinibWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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Correlated MeSH Terms (6)

Name (Synonyms) Correlation
D000163 Acquired Immunodeficiency Syndrome NIH 0.58
D015658 HIV Infections NIH 0.41
D003141 Communicable Diseases NIH 0.09
D007239 Infection NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

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There is one clinical trial.

Clinical Trials

1 An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-JNJ-73841937 (Lazertinib) After a Single Oral Dose in Healthy Male Participants

The purpose of this study is to characterize the absorption, metabolic pathways of lazertinib, and the excretion of the parent lazertinib and its metabolites, after a single oral dose of 14C-lazertinib in healthy adult male participants.

NCT04410081 Healthy Drug: 14C-lazertinib

Primary Outcomes

Description: Cmax is defined as maximum observed plasma concentration.

Measure: Maximum Observed Plasma Concentration (Cmax) of 14C-lazertinib

Time: Up to 99 days

Description: Tmax is defined time to reach the maximum observed concentration.

Measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of 14C-lazertinib

Time: Up to 99 days

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

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

Time: Up to 99 days

Description: 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.

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

Time: Up to 99 days

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

Measure: Elimination Half-life (t1/2) of 14C-lazertinib

Time: Up to 99 days

Description: 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.

Measure: Apparent Terminal Elimination Rate Constant (Lambda[z])

Time: Up to 99 days

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

Measure: Total Apparent Clearance (CL/F) of 14C-lazertinib

Time: Up to 99 days

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

Measure: Apparent Volume of Distribution (Vdz/F) of 14C-lazertinib

Time: Up to 99 days

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

Measure: Ratio of Blood to Plasma Total Radioactivity of 14C-lazertinib

Time: Up to 99 days

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

Measure: Ratio of AUC (0-infinity) of 14C-lazertinib to AUC (0-infinity) of Total Radioactivity in Plasma

Time: Up to 99 days

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

Measure: Ratio of AUC (0-last) of 14C-lazertinib Concentration to AUC (0-last) of Total Radioactivity in Plasma

Time: Up to 99 days

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

Measure: Ratio of Cmax of 14C-lazertinib to Cmax of Total Radioactivity in Plasma

Time: Up to 99 days

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

Measure: Ratio of 14C-lazertinib Concentration to Total Radioactivity in Plasma

Time: Up to 99 days

Description: 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.

Measure: Amount of 14C-lazertinib Excreted in Urine (Ae[t1-t2])

Time: Up to 99 days

Description: 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.

Measure: Cumulative Amount of 14C-lazertinib Excreted in Urine (Ae)

Time: Up to 99 days

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

Measure: Percentage of 14C-lazertinib Dose Excreted in Urine (%Ae)

Time: Up to 99 days

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

Measure: Renal Clearance (CLr) of 14C-lazertinib

Time: Up to 99 days

Description: 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.

Measure: Amount of 14C-lazertinib Excreted in Feces (Fe[t1-t2])

Time: Up to 99 days

Description: 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.

Measure: Cumulative Amount of 14C-lazertinib Excreted in Feces (Fe)

Time: Up to 99 days

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

Measure: Percentage of 14C-lazertinib Dose Excreted in Feces (%Fe)

Time: Up to 99 days

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

Measure: Total Recovery of 14C-lazertinib Dose in Feces and Urine

Time: Up to 99 days

Secondary Outcomes

Description: An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.

Measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Time: Up to 135 days

No related HPO nodes (Using clinical trials)