Use of Artificial Stomach−Duodenum Model for Investigation of Dosing Fluid Effect on Clinical Trial Variability

• Published in: Molecular pharmaceutics Vol. 7; no. 5; pp. 1533 - 1538
• Main Authors: Polster, Christopher S, Atassi, Faraj, Wu, Sy-Juen, Sperry, David C
• Format: Journal Article
• Language: English
• Published: United States American Chemical Society 04.10.2010
• Subjects: Administration, Oral; Analysis of Variance; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - pharmacokinetics; Body Fluids - metabolism; Capsules - administration & dosage; Chemistry, Pharmaceutical - methods; Clinical Trials as Topic; Duodenum - metabolism; Humans; Hydrogen-Ion Concentration; Intestinal Absorption; Models, Biological; Pharmacokinetics; Stomach - metabolism; dosing fluid selection; GI simulation; Artificial stomach duodenum; clinical trial variability; variability mitigation; oncology; gastric pH effect

Lilly Compound X (LCX) is an oncology drug that was tested in a phase I clinical study using starch blend capsules. The drug was given to a small patient population (4 patients) and showed large inter- and intra-patient variability. In order to evaluate the possible effect of stomach pH on exposure...