Background & Problem
The Sponsor’s drug had a very long half-life. It also had three metabolites, one of which was active, that also had very long half-lives. These pharmacokinetic (PK) characteristics of the drug made a typical Drug-Drug Integration (DDI) study design infeasible. Nuventra helped the Sponsor design a study that was both feasible and capable of gathering the necessary information that could improve the development constraints of the program.
Sampling schedules in the study design needed to be very carefully selected in order to get the optimal statistical power to make necessary extrapolations. To address this, Nuventra proposed conducting an optimal sampling project. In this project, our scientists designed a D-optimal sampling strategy for the parent and metabolite. The strategy was used to predict the necessary sample size for having sufficient statistical power in the client’s DDI study. Nuventra then proposed conducting compartmental modeling, and once we had the modeling results, our scientists were able to propose/design a final protocol synopsis.
The study was conducted using our creative study design and protocol synopsis. Our PK report laid out conclusions that helped the client address the development constraints.
Our team was able to conclude from the study that dose adjustments would not be necessary for patients that are also taking drugs that inhibit two enzymes that were thought important for the drug’s metabolism. The Sponsor was able to remove a potential warning/hazard from their drug label.