Status:
COMPLETED
A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
MALE
18-60 years
Phase:
PHASE1
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-lazertini...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04410081
Start Date
July 14 2020
End Date
March 2 2021
Last Update
March 29 2021
Active Locations (1)
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1
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, Netherlands, 9728 NZ