Skip to main content
OpenTrials
Completed

NCT Number: NCT04410081

A Study of (14C)-JNJ-73841937 (Lazertinib) 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 performed at screening. If the results of the serum chemistry or hematology panel are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and body weight not less than 50 kg at screening
  • Blood pressure at screening and admission to the study site (after the participant supine for 5 minutes) between 90 and 140 millimeter of Mercury (mmHg) systolic, inclusive; and no higher than 90 mmHg diastolic at screening
  • A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including: Sinus rhythm, Pulse rate between 45 and 100 beats per minute (bpm), corrected QT (QTc) interval less than or equal to (<=) 450 millisecond (msec), QRS interval of less than (<)120 msec, PR interval <210 msec

Exclusion criteria

  • History of infection suspected or confirmed to be related to Coronavirus disease 2019 (COVID-19) within 4 weeks before intake of study drug
  • Participant has known allergies, hypersensitivity, or intolerance to lazertinib or any of its excipients
  • Participant has a positive test for hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), hepatitis B (anti-HBc or anti-HBs), or hepatitis C (anti-HCV) antibodies positive at screening. Hepatitis B surface antibody positivity is not exclusionary if participant can provide evidence of Hepatitis B vaccination
  • Participant who plans to father a child while enrolled in the study or within 6 months after study drug administration
  • Exposure to radiation for professional or medical reasons with the exception of up to 2 standard diagnostic radiographs (example, [dental X-rays, plain chest X-ray]) within 1 year before study drug administration on Study Day 1. Participants cannot have participated in a radiolabeled drug study within 12 months prior to dosing if the dose was higher than 0.1 megabecquerel (MBq)

Treatment and study plan

14C-lazertinib

Drug

A single oral dose of 14C-lazertinib will be administered.

Other names: JNJ-73841937

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of 14C-lazertinib

    Time frame: Up to 99 days

    Cmax is defined as maximum observed plasma concentration.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of 14C-lazertinib

    Time frame: Up to 99 days

    Tmax is defined time to reach the maximum observed concentration.

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

    Time frame: Up to 99 days

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

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

    Time frame: Up to 99 days

    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.

  5. Elimination Half-life (t1/2) of 14C-lazertinib

    Time frame: Up to 99 days

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

  6. Apparent Terminal Elimination Rate Constant (Lambda[z])

    Time frame: Up to 99 days

    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.

  7. Total Apparent Clearance (CL/F) of 14C-lazertinib

    Time frame: Up to 99 days

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

  8. Apparent Volume of Distribution (Vdz/F) of 14C-lazertinib

    Time frame: Up to 99 days

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

  9. Ratio of Blood to Plasma Total Radioactivity of 14C-lazertinib

    Time frame: Up to 99 days

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

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

    Time frame: Up to 99 days

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

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

    Time frame: Up to 99 days

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

  12. Ratio of Cmax of 14C-lazertinib to Cmax of Total Radioactivity in Plasma

    Time frame: Up to 99 days

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

  13. Ratio of 14C-lazertinib Concentration to Total Radioactivity in Plasma

    Time frame: Up to 99 days

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

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

    Time frame: Up to 99 days

    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.

  15. Cumulative Amount of 14C-lazertinib Excreted in Urine (Ae)

    Time frame: Up to 99 days

    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.

  16. Percentage of 14C-lazertinib Dose Excreted in Urine (%Ae)

    Time frame: Up to 99 days

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

  17. Renal Clearance (CLr) of 14C-lazertinib

    Time frame: Up to 99 days

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

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

    Time frame: Up to 99 days

    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.

  19. Cumulative Amount of 14C-lazertinib Excreted in Feces (Fe)

    Time frame: Up to 99 days

    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.

  20. Percentage of 14C-lazertinib Dose Excreted in Feces (%Fe)

    Time frame: Up to 99 days

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

  21. Total Recovery of 14C-lazertinib Dose in Feces and Urine

    Time frame: Up to 99 days

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

Secondary outcomes

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

    Time frame: Up to 135 days

    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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.