Clinical studies in healthy subjects confirmed the predicted DDIs from in vitro data. Results were used in the DDI section of the drug product label for NDA (New Drug Application).
The client planned to conduct two phase-3 studies to evaluate a small molecule drug being developed as adjunctive therapy. It was essential to evaluate potential drug-drug interactions (DDIs) between the investigational drug and other commonly used 40+ drugs in this patient population.
The sponsor conducted cytochrome P450 (CYP)-mediated and transporter-mediated drug-drug interaction (DDI) studies in vitro. Additional in vitro DDI studies were conducted for uridine diphosphate glucuronosyltransferase (UGT). The client came to XP Pharma to support an urgent need for speedy interpretation of the in vitro study results to determine the potential for clinical DDI with commonly used 40+ drugs in the patient population.
We evaluated seven in vitro DDI studies and four human PK study reports. We identified CYP enzymes as potential perpetrators that affect the pharmacokinetics of the investigational drug. We also identified CYP enzymes that could be affected by the investigational drug. Further, we estimated the effect size based on physiologically based pharmacokinetic (PBPK) assessment based on area under the curve (AUC) ratios. We identified CYPs, UGTs, and transporters that are unlikely to cause potential DDIs with the investigational drug.
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