Clinical trial NCT04410081: A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-06-01
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of 14C-lazertinib
timeFrame: Up to 99 days
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of 14C-lazertinib
timeFrame: Up to 99 days
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC [0-last]) of 14C-lazertinib
timeFrame: Up to 99 days
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of 14C-lazertinib
timeFrame: Up to 99 days
measure: Elimination Half-life (t1/2) of 14C-lazertinib
timeFrame: Up to 99 days
measure: Apparent Terminal Elimination Rate Constant (Lambda[z])
timeFrame: Up to 99 days
measure: Total Apparent Clearance (CL/F) of 14C-lazertinib
timeFrame: Up to 99 days
measure: Apparent Volume of Distribution (Vdz/F) of 14C-lazertinib
timeFrame: Up to 99 days
measure: Ratio of Blood to Plasma Total Radioactivity of 14C-lazertinib
timeFrame: Up to 99 days
measure: Ratio of AUC (0-infinity) of 14C-lazertinib to AUC (0-infinity) of Total Radioactivity in Plasma
timeFrame: Up to 99 days
measure: Ratio of AUC (0-last) of 14C-lazertinib Concentration to AUC (0-last) of Total Radioactivity in Plasma
timeFrame: Up to 99 days
measure: Ratio of Cmax of 14C-lazertinib to Cmax of Total Radioactivity in Plasma
timeFrame: Up to 99 days
measure: Ratio of 14C-lazertinib Concentration to Total Radioactivity in Plasma
timeFrame: Up to 99 days
measure: Amount of 14C-lazertinib Excreted in Urine (Ae[t1-t2])
timeFrame: Up to 99 days
measure: Cumulative Amount of 14C-lazertinib Excreted in Urine (Ae)
timeFrame: Up to 99 days
measure: Percentage of 14C-lazertinib Dose Excreted in Urine (%Ae)
timeFrame: Up to 99 days
measure: Renal Clearance (CLr) of 14C-lazertinib
timeFrame: Up to 99 days
measure: Amount of 14C-lazertinib Excreted in Feces (Fe[t1-t2])
timeFrame: Up to 99 days
measure: Cumulative Amount of 14C-lazertinib Excreted in Feces (Fe)
timeFrame: Up to 99 days
measure: Percentage of 14C-lazertinib Dose Excreted in Feces (%Fe)
timeFrame: Up to 99 days
measure: Total Recovery of 14C-lazertinib Dose in Feces and Urine
timeFrame: Up to 99 days
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to 135 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: