The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of lazertinib in participants with impaired hepatic function when compared with healthy participants with normal hepatic function, under fed conditions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Lazertinib tablet will be administered orally.
CRS Clinical Research Services Kiel GmbH
Kiel, Germany
APEX GmbH
München, Germany
Plasma Concentrations of Lazertinib
Plasma concentrations of lazertinib will be analyzed using a validated, specific, and sensitive method to assess the effect of hepatic impairment on the pharmacokinetic of lazertinib.
Time frame: Predose up to 312 hour postdose (up to Day 14)
Percentage of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to 49 days
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