Trial reportAntimicrobial agents and chemotherapy2026
Pharmacokinetics, safety, and dose optimization of GST-HG171 in renal impairment: insights from physiologically based pharmacokinetic modeling.
Trial report in Antimicrobial agents and chemotherapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
GST-HG171 is an orally administered inhibitor of the 3C-like protease that has been approved in China for the treatment of mild to moderate COVID-19. When co-administered with ritonavir, GST-HG171 is eliminated by the kidney. Therefore, this study evaluated the impact of renal impairment on its pharmacokinetics (PK), safety, and tolerability. A total of 24 participants were enrolled: 8 with normal renal function, 8 with mild renal impairment, and 8 with moderate renal impairment. Participants received 100 mg ritonavir at -12, 0, 12, and 24 h, with a single 150 mg dose of GST-HG171 co-administered at 0 h to maintain CYP3A inhibition. Compared with healthy subjects, mild renal impairment increased GST-HG171 exposure; the geometric least-squares mean ratios (90% confidence intervals) for
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