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| ID | Type | Description | Link |
|---|---|---|---|
| 73841937NSC1004 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-000646-34 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C-lazertinib | Experimental | Participants will receive a single oral dose of 14C-lazertinib on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-lazertinib | Drug | A single oral dose of 14C-lazertinib will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of 14C-lazertinib | Cmax is defined as maximum observed plasma concentration. | Up to 99 days |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of 14C-lazertinib | Tmax is defined time to reach the maximum observed concentration. | Up to 99 days |
| Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC [0-last]) of 14C-lazertinib | AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to the time of last observed quantifiable concentration. | Up to 99 days |
| Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of 14C-lazertinib | 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. | Up to 99 days |
| Elimination Half-life (t1/2) of 14C-lazertinib | Elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve, calculated as 0.693/lambda(z). | Up to 99 days |
| Apparent Terminal Elimination Rate Constant (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | 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. | Up to 135 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini | Groningen | 9728 NZ | Netherlands |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Up to 99 days |
| Total Apparent Clearance (CL/F) of 14C-lazertinib | Clearance is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as dose/AUC (0-infinity). | Up to 99 days |
| Apparent Volume of Distribution (Vdz/F) of 14C-lazertinib | Apparent volume of distribution, calculated as dose/(Lambda(z)*AUC (0-infinity). | Up to 99 days |
| Ratio of Blood to Plasma Total Radioactivity of 14C-lazertinib | Blood to plasma total radioactivity ratio, calculated as blood total radioactivity/plasma total radioactivity. | Up to 99 days |
| Ratio of AUC (0-infinity) of 14C-lazertinib to AUC (0-infinity) of Total Radioactivity in Plasma | The ratio of AUC (0-infinity) of 14C-lazertinib to AUC (0-infinity) of total radioactivity in plasma will be assessed. | Up to 99 days |
| Ratio of AUC (0-last) of 14C-lazertinib Concentration to AUC (0-last) of Total Radioactivity in Plasma | The ratio of AUC (0-last) of 14C-lazertinib to AUC (0-last) of total radioactivity in plasma will be assessed. | Up to 99 days |
| Ratio of Cmax of 14C-lazertinib to Cmax of Total Radioactivity in Plasma | The ratio of Cmax of 14C-lazertinib to Cmax of total radioactivity in plasma will be assessed. | Up to 99 days |
| Ratio of 14C-lazertinib Concentration to Total Radioactivity in Plasma | The ratio of 14C-lazertinib concentration to total radioactivity in plasma for each sampling time point will be assessed. | Up to 99 days |
| Amount of 14C-lazertinib Excreted in Urine (Ae[t1-t2]) | 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. | Up to 99 days |
| Cumulative Amount of 14C-lazertinib Excreted in Urine (Ae) | 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. | Up to 99 days |
| Percentage of 14C-lazertinib Dose Excreted in Urine (%Ae) | Cumulative amount excreted into the urine, expressed as a percentage of the administered dose, calculated as (Ae divided by dose)*100. | Up to 99 days |
| Renal Clearance (CLr) of 14C-lazertinib | The CLr is the renal clearance of the drug, calculated as Ae/AUC(0-infinity). | Up to 99 days |
| Amount of 14C-lazertinib Excreted in Feces (Fe[t1-t2]) | 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. | Up to 99 days |
| Cumulative Amount of 14C-lazertinib Excreted in Feces (Fe) | 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. | Up to 99 days |
| Percentage of 14C-lazertinib Dose Excreted in Feces (%Fe) | Cumulative amount excreted into the feces, expressed as a percentage of the administered dose, calculated as (Fe divided by dose)*100. | Up to 99 days |
| Total Recovery of 14C-lazertinib Dose in Feces and Urine | Total recovery, calculated as sum of %Ae and %Fe. | Up to 99 days |