Netazepide, a gastrin/CCK2 receptor antagonist, causes dose-dependent, persistent inhibition of the responses to pentagastrin in healthy subjects

Br J Clin Pharmacol. 2013 Nov;76(5):689-98. doi: 10.1111/bcp.12099.

Abstract

Aims: To confirm by means of pentagastrin, a synthetic gastrin agonist, that netazepide is a gastrin/CCK2 receptor antagonist in healthy subjects, and that antagonism persists during repeated dosing.

Methods: We did two studies in which we infused pentagastrin (0.6 μg kg(-1) h(-1) intravenously), aspirated gastric secretion and measured the volume, pH and H(+) secretion rate of the gastric aspirate. First, we did a double-blind, five-way crossover study (n = 10) to assess the effect of single oral doses of netazepide (1, 5, 25 and 100 mg) and placebo on the response to pentagastrin. Then, we did a single-blind, placebo-controlled study (n = 8) to assess the effect of the first and last oral doses of netazepide (100 mg) twice daily for 13 doses on the response to pentagastrin.

Results: Netazepide was well tolerated. After placebo, pentagastrin increased the volume and H(+) secretion rate and reduced the pH of gastric aspirate. Compared with placebo, single doses of netazepide caused dose-dependent inhibition of the pentagastrin response (P < 0.02); netazepide (100 mg) abolished the response. After 13 doses, the reduction in volume and H(+) secretion rate persisted (P < 0.001), but the pH effect was mostly lost.

Conclusions: Netazepide is an orally active, potent, competitive antagonist of human gastrin/CCK2 receptors. Antagonism is dose dependent and persists during repeated dosing, despite tolerance to the effect on pH. Further studies are required to explain that tolerance. Netazepide is a tool to study the physiology and pharmacology of gastrin, and merits studies in patients to assess its potential to treat gastric acid-related conditions and the trophic effects of hypergastrinaemia.

Keywords: YF476; gastrin receptor antagonist; netazepide; pentagastrin.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Benzodiazepinones / administration & dosage
  • Benzodiazepinones / adverse effects
  • Benzodiazepinones / pharmacology*
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Tolerance
  • Female
  • Gastrins / metabolism*
  • Humans
  • Hydrogen-Ion Concentration
  • Male
  • Pentagastrin / pharmacology*
  • Phenylurea Compounds / administration & dosage
  • Phenylurea Compounds / adverse effects
  • Phenylurea Compounds / pharmacology*
  • Receptor, Cholecystokinin B / antagonists & inhibitors*
  • Single-Blind Method
  • Young Adult

Substances

  • Benzodiazepinones
  • Gastrins
  • Phenylurea Compounds
  • Receptor, Cholecystokinin B
  • Pentagastrin
  • YF 476