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

NCT ID: NCT04410081

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-14
• Study Completion Date: 2021-03-02

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

14C-lazertinib

Participants will receive a single oral dose of 14C-lazertinib on Day 1.

Group Type: EXPERIMENTAL

14C-lazertinib

Intervention Type: DRUG

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

Interventions

14C-lazertinib

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

Intervention Type: DRUG

Other Intervention Names

JNJ-73841937

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

73841937NSC1004

Identifier Type: OTHER

Identifier Source: secondary_id

2020-000646-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108791

Identifier Type: -

Identifier Source: org_study_id