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

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Food and Drug Administration (FDA)
• Treatments: Rosuvastatin Calcium

Criteria

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.