AGN 201904-Z (AGN), a Novel Enteric-Coated PPI, Produces Greater, More Prolonged Acid Suppression Than Esomeprazole (ESO) in Healthy Male Volunteers
Bibliographic record
Abstract
Purpose: A significant number of patients with acid-related disorders fail to respond adequately to once or even twice daily PPIs due to their short plasma residence time. Thus, there are unmet clinical needs for longer, effective acid suppression. AGN 201904-Z is a new chemical entity, which gives more prolonged blood concentrations of omeprazole due to its novel chemistry to produce prolonged systemic exposure. The rapid conversion to omeprazole results in a prolonged residence time in the blood implying longer effective acid suppression. Methods: A first randomized, open-label, parallel-group, investigator-blinded intra-gastric pH study was performed in 24 healthy H. pylori negative male volunteers. AGN enteric-coated capsules (600 mg, delivering (50 mg molar omeprazole to the systemic circulation) or esomeprazole delayed-release tablets (40 mg) were given once daily before breakfast for 5 consecutive days. Ambulatory 24-h intra-gastric pH was recorded at baseline, and days 1, 3 and 5 of treatment. Subjects maintained a standard diet. Results: See Table 1. On day 1, median pH and% time pH ≥4 were significantly higher with AGN than ESO during the nocturnal period (19:00–07:00). At presumed steady state (day 5), both 24-h and nocturnal pH values and% time pH ≥4 were significantly higher for AGN than ESO. AGN provided mean% of nocturnal time with pH ≥4 more than twice as long as ESO. No safety issues were associated with either drug.Table 1: Mean (±SD) of median pH and% time pH ≥4 at day 1 and 5 by AGN and ESOConclusions: AGN 201904-Z produced significantly greater and more prolonged acid suppression than esomeprazole and nocturnal acid suppression with AGN was also more prolonged over 5-days use. AGN should provide true once-a-day treatment and better clinical efficacy than current PPIs for the management of acid-related diseases responding poorly to conventional oral PPI therapy.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".