I-64

Gastric emptying and its covariates

Adam S. Darwich (1), Alison Margolskee (1), Kayode Ogungbenro (1), Aleksandra Galetin (1), Leon Aarons (1), Amin Rostami-Hodjegan (1,2)

(1) University of Manchester, Manchester, UK, (2) Simcyp Ltd, Certara, Sheffield, UK.

Objectives: Gastric emptying plays an important role in governing the rate of oral drug absorption of readily absorbed drugs. The aim of this study was to characterise the influence of covariates on gastric emptying in a quantitative manner.

Methods: An extensive literature search was carried out using PubMed (1950-May 2014) in order to identify publications of clinical trials investigating gastric emptying. Quantitative measures of gastric emptying were recorded, including gastric emptying rate, half-life, lag time, and a number of other predefined variables. A statistical meta-analysis approach was applied in order to develop a multivariable linear regression model based on identified significant covariates.

Results: Over 4,000 articles were identified according to the search criteria, out of these over 1,000 publications containing over 3,000 study arms fulfilled the criteria and were included in the meta-analysis. Data analysis concluded general demographics such as age, weight, height and gender, to have little or no impact on gastric emptying, instead most of the variability was explained by caloric content, meal composition and solid/liquid state.

Conclusions: This work presents a multivariable linear regression model with potential applicability in pharmacokinetic modelling in order to account for covariate effects on gastric emptying.

Reference: PAGE 24 () Abstr 3574 [www.page-meeting.org/?abstract=3574]

Poster: Drug/Disease modeling - Absorption & PBPK