To accelerate clinical development of new candidate drugs, in certain cases drug-drug interaction (DDI) assessments can be combined into a single DDI study by administering a cocktail of several substrate drugs. This approach allows the simultaneous evaluation of a novel drug’s inhibition and induction potential for multiple CYP450 enzymes and drug transporters. Such studies, however, need to satisfy specific criteria to enable safe conduct and yield reliable pharmacokinetic (PK) data. A critical aspect, for instance, is that the cocktail of substrate drugs and their applied dose levels must have been validated for use in such DDI studies. This presentation will provide an overview of the most common, validated cocktail drug combinations used today, as well as bioanalytical considerations and regulatory perspectives for drug development. In addition, best practices for the design and conduct of cocktail DDI studies along with illustrative case examples will be presented.
Key takeaways: - Properly designed and well-executed cocktail DDI studies offer an efficient approach to evaluate several DDIs in a single study - Only a handful of validated drug cocktails are commonly applied in DDI studies, covering the main metabolic and drug transport routes - Bioanalytical assays can be optimized to increase sensitivity and reduce blood sample volume to maximize sample analysis
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