Drug Interactions Clinical Trial
Official title:
An Open-label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Cytochrome P450 Probe Drugs in Healthy Adult Subjects
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.
The primary purpose of this study is to establish a validated drug cocktail, containing up to
7 probes, for assessing the activity of six drug metabolizing enzymes (CYP 1A2, 2C8, 2C9,
2C19, 2D6, 3A4/5) and the OATP1B1 transporter. In Part 1, the study will determine if there
are pharmacokinetic interactions among the probe drugs by comparing the pharmacokinetics of
the probe drugs when administered alone and in combination (i.e., as a cocktail). In Part 2,
the study will evaluate the quantitative performance of the cocktail by examining the effect
of select inhibitors on the pharmacokinetics of respective probe drugs when the probe drugs
are administered alone versus when administered in the cocktail.
This study aims to establish a standard probe cocktail that can be used for drug-drug
interaction studies, with the intention that any subset of the 7-drug cocktail could be
selected for study with a drug in development.
In addition, this study will provide a proof-of-principle evaluation of dried blood spot
technology as a method to measure drug concentrations in blood samples collected from
clinical studies.
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