Predictable prolonged suppression of gastric acidity with a novel proton pump inhibitor, AGN 201904‐Z
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abstract
SummaryBackground 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 ≥4 and 24‐h and nocturnal time pH ≥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.
