Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: This is a single center, randomized, two-treatment crossover trial.Masking: Single (Participant)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 64 years
- Gender
- Both males and females
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 ...
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 randomized, two-arm crossover study, subjects will undergo a placebo and 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.
Tracking Information
- NCT #
- NCT04542382
- Collaborators
- Food and Drug Administration (FDA)
- Investigators
- Principal Investigator: Kathleen M Giacomini, Ph.D. University of California, San Francisco