Pharmacokinetics of neratinib during coadministration with lansoprazole in healthy subjects.

ABSTRACT:

Aims

To evaluate the effect of lansoprazole, a proton-pump inhibitor, on the absorption, pharmacokinetics, and safety of neratinib, a pan-HER tyrosine kinase inhibitor, in healthy subjects.

Methods

This was an open-label, two-period, fixed-sequence study. Fifteen healthy adult subjects received a single oral dose of neratinib 240 mg (Period 1), followed by a washout period, then oral lansoprazole 30 mg once daily for 7 days and a single dose of neratinib 240 mg on Day 5 (Period 2). Pharmacokinetic sampling was performed for 72 h following each neratinib dose. Plasma neratinib concentration-time data were analysed using noncompartmental methods. Geometric mean ratios for AUC_0-t , AUC_0-inf , and peak plasma concentrations (C_max ) for neratinib

SUBMITTER: Keyvanjah K 

PROVIDER: S-EPMC5306479 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature