Open Label Study for the Functional Characterization of Drug Metabolism and Transport
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
Aim of this study is to comprehensively assess in healthy volunteers the metabolic processes
and factors that define drug response. Sources of variability are to be investigated and
factors that can alter the hepatic metabolism and the pharmacokinetics of drugs shall be
quantified.
Determination of variability is important when the pharmacokinetics of new drugs is being
investigated and when the concept of individualized medicine is to be further developed. It
is important to identify and differentiate between pharmaceutical, physiological (e.g. liver
blood flow, renal function), environmental (e.g. foods and lifestyle), and genetic sources of
inter-individual variability. For instance, inaccurate or false conclusions may be drawn from
a single pharmacokinetic study, if the investigated medicine is metabolized by an enzyme with
large inter-individual variability. Knowing the causes of variability and of the quantitative
contribution of various processes might help to improve the oral formulations of drugs, might
help selecting the right preclinical tests and selection criteria during clinical
development, provide the basis to understand the influence of disease and to optimize
established drug treatments in order to make future drug treatment safer and more efficient.
This study is designed as an add-on to the study "TWINS: Open Label Repeated Dose Study for
the Evaluation of Heritability of and Genetic Influences on Drug Pharmacokinetics" (Eudra-CT:
2008-006223-31). Twins are not a random sample of the population, and they differ in their
developmental environment. In this sense they are not representative for the population Thus,
the results of TWINS cannot be automatically generalized but instead require validation in a
representative population sample. While both studies assess pharmacologic factors important
for drug response, TWINS contributes in particular data on the heritability of these
processes.