A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants

  • STATUS
    Recruiting
  • participants needed
    8
  • sponsor
    Janssen Research & Development, LLC
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Updated on 19 February 2024
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electrocardiogram
12 lead electrocardiogram

Summary

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.

Details
Condition Healthy
Age 18-60 years
Treatment 14C-lazertinib
Clinical Study IdentifierNCT04410081
SponsorJanssen Research & Development, LLC
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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