Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation
Status:
Completed
Trial end date:
2011-08-29
Target enrollment:
Participant gender:
Summary
The purpose of this study is to identify and validate a probe cocktail for use in future
drug-drug interaction studies. Cytochrome P450 enzymes and transport proteins play important
roles in the disposition of drugs. Changes in the activity of these pathways can be assessed
using probe drugs selected on the basis of their metabolic or transport pathway. This will be
a two part study with the same subjects participating in both parts to decrease variability
in data. The purpose of Part 1 is to identify a set of probe drugs ('cocktail') which do not
interact with one another; groups of healthy volunteers will receive 7 probe drugs
individually and as a combination of the 7 drugs given together as a cocktail. Part 2 will
assess the performance of the probe cocktail using three known inhibitors (validation). The
inhibitors plus probe cocktail will evaluate the ability of the newly established cocktail to
accurately quantify metabolizing enzyme or transporter inhibition, representing a fundamental
advance in probe cocktail validation and utility for drug development.