Identification and Validation of Biomarkers for Breast Cancer Resistance Protein

20-30638

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).

2022-02-01

2024-12-01

2024-12-01

Active (not recruiting)

Early phase I

20

Inclusion Criteria: * Healthy as judged by medical examination, medical history and normal biochemical and hematological measures. * Normal urinalysis and renal function * Male subjects weighing ≥ 50 kg and female subjects weighing ≥ 45 kg. * Understand the nature and purpose of the study and provide informed consent. Exclusion Criteria: * Subjects who are pregnant, breastfeeding, or unwilling to practice non-hormonal forms of birth control during participation in the study. * Self-reported drug allergies to rosuvastatin or eltrombopag * Subjects that have smoked cigarettes, have smoked or ingested THC/marijuana or have used illegal substances (i.e., opiates, cocaine) in the past year. * Subjects with any disease affecting or impairing the function of the liver, kidney or heart. * Subjects with any blood or coagulation disorders. * Subjects with diabetes mellitus, hyperthyroidism, hypothyroidism, cardiovascular disease, glaucoma. * Subjects with gastrointestinal disease, gastrointestinal disorder, or gastrointestinal surgery. * Subjects with known infection with HIV, Hepatitis B (HBsAg) or Hepatitis C (no laboratory diagnostics concerning these diseases will be performed within the present study). * Subjects that are taking prescription (i.e., birth control pills), non-prescription and dietary supplements (i.e., turmeric, quercetin, kaempferol, Gingko biloba) within seven days of receiving the study dose in each phase of the study. * Subjects with a condition, disease, or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. * Female subjects undergoing treatment for infertility or hormone replacement therapy. * Subjects with abnormal laboratory results at screening as judged by the investigator or study physician. * Participating in another research study while participating in this research study. * Subjects that ingest grapefruit, grapefruit juice or grapefruit extract within seven days of receiving the study dose in each phase of the study. * Non-English speaking. * Subject has any signs or symptoms that are consistent with COVID-19. Per current CDC recommendations this includes subjects with the symptoms cough or shortness of breath or difficulty breathing, or at least two of the following symptoms: fever, chills, repeated shaking with chills, muscle pain, headache, sore throat or new loss of taste/smell. In addition, the subject has any other findings suggestive of COVID-19 risk in the opinion of the investigator. * Subject tests positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by a molecular diagnostic test (i.e., COVID19 RNA test) performed during the screening visit.

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2024-01-23