ArticleClinical drug investigation2025
Clinical Pharmacokinetic Assessment of Lazertinib in Healthy Adult Participants: Effects of GSTM1 Genotype.
Article in Clinical drug investigation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-label, Single-dose Phase 1 Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448 in Healthy Korean and Caucasian Volunteers
An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-JNJ-73841937 (Lazertinib) After a Single Oral Dose in Healthy Male Participants
A Phase 1, Open-label, Study in Healthy Participants to Evaluate the Effect of Steady State Concentrations of Lazertinib (JNJ-73841937) on the Single-dose Pharmacokinetics of Probe Substrates (Midazolam, Rosuvastatin, and Metformin)
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10 authors.
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Abstract
BACKGROUND AND
objectiveLazertinib, a potent and irreversible third-generation oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), has shown promising efficacy and favorable tolerability in EGFR-mutated non-small cell lung cancer (NSCLC). On the basis of in vitro findings, lazertinib is primarily metabolized by glutathione conjugation via glutathione-S-transferase mu 1 (GSTM1), occurring via enzymatic activity of GST or non-enzymatic processes, as well as through cytochrome P450 3A4. Here, we report the effect of GSTM1 on lazertinib pharmacokinetics (PK) using clinical evaluations.
methodsThe effect of GSTM1 on lazertinib PK was evaluated in multiple phase 1 pharmacology studies. Clinical studies (NCT03556436, NCT04410081, and NCT05076877) involving healthy adult participants given lazertinib were analyzed on the basis of GSTM1 genotype (null [i.e., no expression] or non-null [i.e., expression]).
resultsIn a clinical study where participants were genotyped and analyzed to determine the association of lazertinib plasma maximum concentration (C
conclusionsOverall, GSTM1 status affected lazertinib PK in healthy participants and hence further research is warranted to determine the magnitude of PK differences and whether they are clinically meaningful in the NSCLC patient population intended to be treated with lazertinib.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.