Tian X, Esmaeili H, Minich D, Seitz F, Roessner PM, Wind S, Grempler R, Gan G, Chan TS, Mahmoudi M, Sadrolhefazi B, Müller F (2024)
Publication Type: Journal article
Publication year: 2024
DOI: 10.1002/phar.4641
Introduction: Zongertinib (BI 1810631) is a potent, selective, and epidermal growth factor receptor (EGFR) wild-type sparing human epidermal growth factor receptor 2 (HER2) inhibitor. Based on in vitro data, the oxidative hepatic metabolism of zongertinib is principally driven by cytochrome P450 (CYP) 3A4/5. Therefore, zongertinib may be affected by strong CYP3A inducers, like carbamazepine. Objective: This study aimed to investigate the effect of multiple oral doses of carbamazepine on the pharmacokinetics of a single oral dose of zongertinib in healthy male subjects. Methods: This open-label, two-period, fixed-sequence clinical drug–drug interaction study examined the pharmacokinetics of a single 60-mg oral dose of zongertinib in the absence or presence of multiple oral doses of carbamazepine. The extent of drug–drug interaction was estimated using the adjusted geometric mean ratios (and 90% confidence intervals [CIs]) for the test treatment (zongertinib in the presence of carbamazepine) versus the reference treatment (zongertinib alone) for areas under the plasma concentration–time curve from time 0 to infinity and to the last quantifiable time point (AUC
APA:
Tian, X., Esmaeili, H., Minich, D., Seitz, F., Roessner, P.M., Wind, S.,... Müller, F. (2024). The effect of carbamazepine, a strong CYP3A inducer, on the pharmacokinetics of zongertinib in healthy male volunteers. Pharmacotherapy. https://doi.org/10.1002/phar.4641
MLA:
Tian, Xiaofan, et al. "The effect of carbamazepine, a strong CYP3A inducer, on the pharmacokinetics of zongertinib in healthy male volunteers." Pharmacotherapy (2024).
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