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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 and 72 hours
Awards & highlights

BCRPmarker Trial 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.Check my eligibility
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.See study design
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.

BCRPmarker Trial Eligibility Criteria

Inclusion Criteria

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

BCRPmarker Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of pharmacokinetics of co-administration of rosuvastatin and eltrombopag in healthy volunteers.
Secondary outcome measures
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

BCRPmarker 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
~970
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
2,501 Previous Clinical Trials
15,236,551 Total Patients Enrolled
Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,586 Total Patients Enrolled
Kathleen M Giacomini, Ph.D.Principal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
12 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for participants to join this experiment at the present time?

"The clinical trial currently seeks participants and was initially posted on February 1st, 2022. As per the information from clinicaltrials.gov, it has most recently been revised as of November 29th, 2022."

Answered by AI

Are individuals younger than sixty being admitted to this medical trial?

"This medical trial has an age range for participation of 18 to 64."

Answered by AI

Is there any risk associated with the consumption of Rosuvastatin?

"Rosuvastatin's safety is rated at a 1, as this Phase 1 trial does not have sufficient clinical evidence to support its efficacy and security."

Answered by AI

Is it possible for me to become a participant in this experiment?

"The researchers are in need of 20 volunteers, aged between 18 and 64, with healthy subject (hs) status. Additionally, male participants will be required to weigh at least 50 kg and female enrollees must register a weight of 45 kilograms or more."

Answered by AI

In what contexts is Rosuvastatin typically administered?

"Rosuvastatin is commonly employed to mitigate the effects of homozygous familial hypercholesterolemia, hypertriglyceridemias, and cardiovascular disease."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Ucsf Ctsi Crc
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Help science advance medicines. . Understand clinical trials.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)
2022. "Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04542382.
~4 spots leftby Dec 2024
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