Pharmacokinetic study of SAL0140 tablets in patients with varying degrees of renal insufficiency and in matched healthy trial participants with normal renal function
Abstract
Aims SAL0140 is a novel aldosterone synthase inhibitor (ASI) developed as a Class 1 innovative drug in China. This study evaluated the effect of renal impairment on the pharmacokinetics of SAL0140 to support clinical dosing recommendations in patients with impaired renal function. Methods A single-dose, non-randomized, open-label, and parallel-control phase I study was performed. Pharmacokinetics and safety of SAL0140 tablets were evaluated. Results A total of 24 participants completed the study. Following a single oral dose of SAL0140, plasma exposure was comparable between participants with mild or moderate renal impairment and those with normal renal function. The GMRs (90% CIs) for Cmax, AUC0–t, and AUC0–∞ were 84.44% (65.00–109.69%), 88.27% (71.74–108.62%), and 88.18% (71.87–108.20%) in the mild renal impairment group, and 86.94% (66.92–112.93%), 86.69% (70.45–106.67%), and 86.78% (70.72–106.47%) in the moderate renal impairment group, respectively, compared with participants with normal renal function. The median Tmax and terminal half-life were similar across groups. Urinary recovery of unchanged SAL0140 was low, indicating limited renal excretion. No apparent effect of mild or moderate renal impairment on urinary elimination was observed. Conclusion In participants with mild or moderate renal impairment, SAL0140 exposure was not affected to a clinically meaningful extent. In addition, SAL0140 exhibited limited renal clearance, indicating that renal elimination does…
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