1. Academic Validation
  2. Predictable prolonged suppression of gastric acidity with a novel proton pump inhibitor, AGN 201904-Z

Predictable prolonged suppression of gastric acidity with a novel proton pump inhibitor, AGN 201904-Z

  • Aliment Pharmacol Ther. 2008 Jul;28(2):187-99. doi: 10.1111/j.1365-2036.2008.03725.x.
R H Hunt 1 D Armstrong M Yaghoobi C James Y Chen J Leonard J M Shin E Lee D Tang-Liu G Sachs
Affiliations

Affiliation

  • 1 Division of Gastroenterology, McMaster University and Hamilton Health Science Centre, Hamilton, ON, Canada. huntr@mcmaster.ca
Abstract

Background: AGN 201904-Z is a new, slowly absorbed, acid-stable pro-proton pump inhibitor (pro-PPI) rapidly converted to omeprazole in the systemic circulation giving a prolonged residence time.

Aim: To investigate pharmacodynamics and pharmacokinetics of AGN 201904-Z compared to esomeprazole.

Methods: A randomized, open-label, parallel group, investigator-blinded intragastric pH study was conducted in 24 healthy Helicobacter pylori negative male volunteers. AGN 201904-Z enteric-coated capsules (600 mg/day) or esomeprazole delayed-release tablets (40 mg/day) were administered for 5 days. Twenty-four-hour intragastric pH recordings were acquired at baseline, days 1, 3 and 5 with blood levels of omeprazole, AGN 201904-Z and Gastrin.

Results: On day 1, median nocturnal pH and proportion of nocturnal time with pH >or=4 and 24-h and nocturnal time pH >or=5 were significantly higher with AGN 201904-Z than esomeprazole. At day 5, 24-h and median nocturnal pH were significantly higher for AGN 201904-Z than esomeprazole (P < 0.0001). There was also a marked reduction in periods of nocturnal pH <4.0. Area under curve of the AGN 201904-Z active metabolite (omeprazole) in the blood was twice that of esomeprazole at day 5.

Conclusions: AGN 201904-Z produced a significantly greater and more prolonged acid suppression than esomeprazole, and nocturnal acid suppression was more prolonged over all 5 days. AGN 201904-Z should provide true once-a-day treatment and better clinical efficacy than current PPIs.

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