Spots Global Cancer Trial Database for Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)

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Trial Identification

Brief Title: Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)

Official Title: Identification and Validation of Biomarkers for Breast Cancer Resistance Protein

Study ID: NCT04542382

Conditions

Healthy Volunteers

Interventions

Rosuvastatin

Rosuvastatin (Inhibitor arm)

Eltrombopag

Study Description

Brief Summary: This is an open-label, non-randomized, fixed-sequence study. Subjects will undergo a rosuvastatin phase and eltrombopag and rosuvastatin phase to identify biomarkers for Breast Cancer Resistance Protein (BCRP).

Detailed Description: Membrane transporters are critical in the absorption, distribution and elimination of drugs, and are important target sites for drug-drug interactions (DDIs). During drug development, clinical studies characterizing transporter-mediated DDIs are frequently required. There has been enormous interest in identifying and validating serum biomarkers or surrogate probes to be used in predicting in vivo (clinical) DDIs. These biomarkers could complement in vitro studies, reducing false positive and false negative predictions, as well as the cost and time required for clinical development. In this open-label, non-randomized, fixed-sequence study, subjects will undergo a rosuvastatin phase and eltrombopag and rosuvastatin phase to identify biomarkers for a membrane transporter known as Breast Cancer Resistance Protein (BCRP). The primary goal of this study is to validate and discover BCRP candidate biomarkers in a focused clinical DDI study with healthy volunteers to determine whether they can serve as clinical biomarkers for BCRP-mediated DDIs.