Transl Clin Pharmacol.  2020 Sep;28(3):136-146. 10.12793/tcp.2020.28.e16.

Pharmacodynamic evaluation of YH4808 for Helicobacter pylori eradication in healthy subjects

Affiliations
  • 1Department of Clinical Pharmacology, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea
  • 2Department of Pharmacology, Yonsei University College of Medicine, Seoul 03722, Korea
  • 3Clinical Development Department, R&D Division, Yuhan Corporation, Seoul 03722, Korea
  • 4Department of Pediatrics, Yonsei University College of Medicine, Seoul 03722, Korea

Abstract

YH4808 is a novel selective potassium-competitive acid blocker demonstrated to be safe and to have inhibitory effects against gastric acid secretion in previous studies. A randomized, open-label, multiple-dose, 3-treatment, 1-period, parallel design study was conducted to compare the Helicobacter pylori eradication rates and acid suppression capacities of three regimens in 60 healthy subjects with H. pylori-positive, and the potential of YH4808 to replace proton-pump inhibitors (PPIs) in standard regimens for H. pylori eradication. Group 1 received YH4808, amoxicillin, and clarithromycin as a novel triple regimen, while Group 2 received YH4808 and amoxicillin only, and Group 3 received esomeprazole, amoxicillin, and clarithromycin, as the standard triple regimen. H. pylori eradication rates were 85.0% for Group 1, 25.0% for Group 2, and 83.3% for Group 3. Relative response rate between Group 1 and 3 was 1.02 (0.50–2.07; 95% CI, χ2 test p = 0.8881). Furthermore, the novel triple regimen, YH4808, amoxicillin, and clarithromycin, stably inhibited acid secretion and maintained a gastric pH greater than 4 or 5 for 24 hours, which was comparable to the pH range in the standard triple regimen. However, the onset times of the YH4808 regimens were earlier than that for the regimens using esomeprazole. There were no differences in the incidences or severity of adverse events among the three groups. Overall, the novel triple regimen was safe and well-tolerated. YH4808 could replace PPIs in standard triple regimens used for H. pylori eradication.

Keyword

YH4808; H. pylori; Esomeprazole; Pharmacodynamics
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