Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)
NCT04542382 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2025-03-30
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).
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
Rosuvastatin
Rosuvastatin will be administered as follows: Day 1: single dose of 10 mg Rosuvastatin tablet.
- DRUG
-
Rosuvastatin (Inhibitor arm)
Rosuvastatin will be administered as follows: Day 8: single dose of 10 mg Rosuvastatin tablet.
- DRUG
-
Eltrombopag
Eltrombopag will be administered as follows: Day 8: single dose of 75 mg Eltrombopag tablet.
Sponsors & Collaborators
-
Food and Drug Administration (FDA)
collaborator FED -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Kathleen M Giacomini, Ph.D. · University of California, San Francisco
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-28
- Primary Completion
- 2023-08-11
- Completion
- 2023-08-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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