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

NCT04542382 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 20-30638
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Keywords

membrane transporter; drug-drug interaction; rosuvastatin; eltrombopag; biomarker

Outcome Measures

Primary Outcomes (2)

• Composite of pharmacokinetics of co-administration of rosuvastatin and eltrombopag in healthy volunteers.

  Mean difference in area under the curve (AUC) between rosuvastatin 10mg + placebo versus rosuvastatin 10mg + eltrombopag 75mg

  24 and 72 hours

• Composite of pharmacokinetics of co-administration of rosuvastatin and eltrombopag in healthy volunteers.

  Mean difference in Cmax between rosuvastatin 10mg + placebo versus rosuvastatin 10mg + eltrombopag 75mg

  24 hour

Secondary Outcomes (1)

• Composite of BCRP biomarkers of co-administration of rosuvastatin and eltrombopag in healthy volunteers.

  24 and 72 hours

Study Arms (2)

Placebo and Rosuvastatin

EXPERIMENTAL

Subjects will be dosed with placebo tablet and Rosuvastatin 10mg tablet

Drug: Rosuvastatin

Eltrombopag and Rosuvastatin

EXPERIMENTAL

Subjects will be dosed with Eltrombopag 75mg tablet and Rosuvastatin 10mg tablet

Drug: Rosuvastatin (Inhibitor arm); Drug: Eltrombopag

Interventions

Rosuvastatin DRUG

Rosuvastatin will be administered as follows: Day 1: single dose of 10 mg Rosuvastatin tablet.

Also known as: Crestor

Placebo and Rosuvastatin

Rosuvastatin (Inhibitor arm) DRUG

Rosuvastatin will be administered as follows: Day 8: single dose of 10 mg Rosuvastatin tablet.

Also known as: Cresto

Eltrombopag and Rosuvastatin

Eltrombopag DRUG

Eltrombopag will be administered as follows: Day 8: single dose of 75 mg Eltrombopag tablet.

Also known as: Promacta

Eltrombopag and Rosuvastatin

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Ucsf Ctsi Crc

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; eltrombopag

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kathleen M Giacomini, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center, an open-label, non-randomized, fixed-sequence study.

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 9, 2020
• Study Start: October 28, 2021
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)