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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04410081
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 14, 2020
Status verified
Mar 2021
Primary completion
Mar 2, 2021
Completion
Mar 2, 2021

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of 14C-lazertinib [ Time Frame: Up to 99 days ]

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