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Statins

Rosuvastatin + Eltrombopag for Healthy Subjects (BCRPmarker Trial)

Phase 1
Waitlist Available
Led By Kathleen M Giacomini, Ph.D.
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal urinalysis and renal function
Male subjects weighing ≥ 50 kg and female subjects weighing ≥ 45 kg
Must not have
Subjects with any blood or coagulation disorders
Subjects with gastrointestinal disease, gastrointestinal disorder, or gastrointestinal surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 and 72 hours
Awards & highlights
No Placebo-Only Group

Summary

This trialinvestigates biomarkers to understand how drugs interact with the body to help fight breast cancer.

Who is the study for?
This trial is for healthy adults with normal kidney function and body weight (≥50 kg for males, ≥45 kg for females). Participants must understand the study and consent to it. Excluded are those pregnant, breastfeeding, using certain birth control methods or drugs, with liver/kidney/heart diseases, blood disorders, diabetes, thyroid issues, glaucoma or gastrointestinal problems.
What is being tested?
The study tests how Rosuvastatin alone and combined with Eltrombopag affects biomarkers related to Breast Cancer Resistance Protein (BCRP) in healthy individuals. It's an open-label study where everyone knows what treatment they're getting; it's not randomized but follows a fixed sequence of treatments.
What are the potential side effects?
Possible side effects include reactions typical of statins like Rosuvastatin such as muscle pain or weakness and digestive issues. Eltrombopag may cause headaches, nausea or potentially affect liver function. Side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function and urine tests are normal.
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I am a man weighing at least 50 kg or a woman weighing at least 45 kg.
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I am a man weighing 50 kg or more, or a woman weighing 45 kg or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a blood or clotting disorder.
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I have had gastrointestinal issues or surgery.
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My liver, kidney, or heart function is not impaired.
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I do not speak English.
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I do not have HIV, Hepatitis B, or Hepatitis C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 and 72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 and 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite of pharmacokinetics of co-administration of rosuvastatin and eltrombopag in healthy volunteers.
Secondary study objectives
Composite of BCRP biomarkers of co-administration of rosuvastatin and eltrombopag in healthy volunteers.

Side effects data

From 2018 Phase 4 trial • 12 Patients • NCT03074630
8%
genital fungal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adverse Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo and RosuvastatinExperimental Treatment1 Intervention
Subjects will be dosed with placebo tablet and Rosuvastatin 10mg tablet
Group II: Eltrombopag and RosuvastatinExperimental Treatment2 Interventions
Subjects will be dosed with Eltrombopag 75mg tablet and Rosuvastatin 10mg tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eltrombopag
2013
Completed Phase 4
~960
Rosuvastatin
2019
Completed Phase 4
~3150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,593 Previous Clinical Trials
14,887,930 Total Patients Enrolled
Food and Drug Administration (FDA)FED
181 Previous Clinical Trials
1,548,629 Total Patients Enrolled
Kathleen M Giacomini, Ph.D.Principal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
12 Total Patients Enrolled
~5 spots leftby Dec 2025
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