Lazertinib
DrugLazertinib tablet will be administered orally.
Other names: JNJ-73841937,, YH25448
NCT Number: NCT05112952
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
CRS Clinical Research Services Kiel GmbH, Kiel, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All Participants:
Healthy Participants with normal hepatic function:
Participants with hepatic impairment:
Exclusion criteria
All Participants:
Lazertinib tablet will be administered orally.
Other names: JNJ-73841937,, YH25448
Time frame: Predose up to 312 hour postdose (up to Day 14)
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: Up to 49 days
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.
Janssen Research & Development, LLC
Industry
A Single-Dose, Open-Label, Parallel-Group, Multi-Center Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Lazertinib (JNJ-73841937)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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