Center for Global Research Data

Assessment of the drug-drug interactions risks of drugs based on the clinical data of the plasma biomarkers

Lead Investigator: Hiroyuki Kusuhara, University of Tokyo
Title of Proposal Research:  Assessment of the drug-drug interactions risks of drugs based on the clinical data of the plasma biomarkers
Vivli Data Request: 7835
Funding Source: Japan Society for the Promotion of Science (JSPS)
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Concomitant use of multiple drugs can increase the risk of drug drug interactions (DDI) that alter exposure of either or both drugs in the body, and thereby influencing drug effects. To avoid harmful DDI in clinical settings is one of the major concerns in drug development. Mathematical model approaches have greatly advanced the prediction of DDI magnitude. The plasma biomarkers have emerged to capture DDI risks of the drugs in humans. The time profiles of the biomarker following drug administration is informative to capture the risk of DDI of the drug. We have proposed a simple method to estimate the parameter of the drugs essential for DDI simulation using the mathematical models based on clinical data of the biomarker. This study focused on glecaprevir which was reported to alter the plasma biomarker for DDI in the exposure dependent manner in healthy subjects. The DDI risk of glecaprevir will be analyzed using our mathematical approach.

 

Requested Studies:

A Comparison of the Bioavailability of Experimental Glecaprevir/Pibrentasvir Formulations with Glecaprevir/Pibrentasvir Film-Coated Bilayer Tablets in Healthy Adult Subjects
Data Contributor: AbbVie
Sponsor ID: M15-540