Healthy VolunteersPhase 1BCRPmarkerNCT04542382
Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)
A Phase 1 study testing Rosuvastatin, Rosuvastatin (Inhibitor arm) and Eltrombopag in people with Healthy Volunteers, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Rosuvastatin, Rosuvastatin (Inhibitor arm) and Eltrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2021to 11 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Validation of Biomarkers for Breast Cancer Resistance Protein
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).
Read the detailed description
Membrane transporters are critical in the absorption, distribution and elimination of drugs, and are important target sites for drug-drug interactions (DDIs). During drug development, clinical studies characterizing transporter-mediated DDIs are frequently required. There has been enormous interest in identifying and validating serum biomarkers or surrogate probes to be used in predicting in vivo (clinical) DDIs. These biomarkers could complement in vitro studies, reducing false positive and false negative predictions, as well as the cost and time required for clinical development.
In this open-label, non-randomized, fixed-sequence study, subjects will undergo a rosuvastatin phase and eltrombopag and rosuvastatin phase to identify biomarkers for a membrane transporter known as Breast Cancer Resistance Protein (BCRP). The primary goal of this study is to validate and discover BCRP candidate biomarkers in a focused clinical DDI study with healthy volunteers to determine whether they can serve as clinical biomarkers for BCRP-mediated DDIs.
- Conditions
- Healthy Volunteers
- Being tested
- Rosuvastatin, Rosuvastatin (Inhibitor arm), Eltrombopag
- Keywords
- membrane transporter, drug-drug interaction, rosuvastatin, eltrombopag, biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Rosuvastatin will be administered as follows:
Day 1: single dose of 10 mg Rosuvastatin tablet.
Rosuvastatin (Inhibitor arm)Drug
Also called Cresto
Rosuvastatin will be administered as follows:
Day 8: single dose of 10 mg Rosuvastatin tablet.
EltrombopagDrug
Also called Promacta
Eltrombopag will be administered as follows:
Day 8: single dose of 75 mg Eltrombopag tablet.
| Study group | Role | What they receive |
|---|---|---|
| Placebo and Rosuvastatin | Experimental | Subjects will be dosed with placebo tablet and Rosuvastatin 10mg tablet Receives: Drug: Rosuvastatin |
| Eltrombopag and Rosuvastatin | Experimental | Subjects will be dosed with Eltrombopag 75mg tablet and Rosuvastatin 10mg tablet Receives: Drug: Rosuvastatin (Inhibitor arm); Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 hour
Secondary outcomes (1)
Composite of BCRP biomarkers of co-administration of rosuvastatin and eltrombopag in healthy volunteers.
Mean difference in BCRP biomarker Cmax between rosuvastatin 10mg + placebo vs rosuvastatin 10mg + eltrombopag 75mg
Measured: 24 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start28 Oct 2021
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a single center, an open-label, non-randomized, fixed-sequence study.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Kathleen M Giacomini, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542382
- Sponsor's protocol ID
- 20-30638
- Acronym
- BCRPmarker
- Status last verified
- Mar 2025
- First submitted
- 25 Aug 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Validation of Biomarkers for Breast Cancer Resistance Protein
- ClinicalTrials.gov ID
- NCT04542382
- Acronym / sponsor ID
- BCRPmarker / 20-30638
- Conditions
- Healthy Volunteers
- Keywords
- membrane transporter, drug-drug interaction, rosuvastatin, eltrombopag, biomarker
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Membrane transporters are critical in the absorption, distribution and elimination of drugs, and are important target sites for drug-drug interactions (DDIs). During drug development, clinical studies characterizing transporter-mediated DDIs are frequently required. There has been enormous interest in identifying and validating serum biomarkers or surrogate probes to be used in predicting in vivo (clinical) DDIs. These biomarkers could complement in vitro studies, reducing false positive and false negative predictions, as well as the cost and time required for clinical development.
In this open-label, non-randomized, fixed-sequence study, subjects will undergo a rosuvastatin phase and eltrombopag and rosuvastatin phase to identify biomarkers for a membrane transporter known as Breast Cancer Resistance Protein (BCRP). The primary goal of this study is to validate and discover BCRP candidate biomarkers in a focused clinical DDI study with healthy volunteers to determine whether they can serve as clinical biomarkers for BCRP-mediated DDIs.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single center, an open-label, non-randomized, fixed-sequence study.
| Arm | Type | Receives |
|---|---|---|
| Placebo and Rosuvastatin | Experimental | Drug: RosuvastatinSubjects will be dosed with placebo tablet and Rosuvastatin 10mg tablet |
| Eltrombopag and Rosuvastatin | Experimental | Drug: Rosuvastatin (Inhibitor arm), Drug: EltrombopagSubjects will be dosed with Eltrombopag 75mg tablet and Rosuvastatin 10mg tablet |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: CrestorRosuvastatin will be administered as follows: Day 1: single dose of 10 mg Rosuvastatin tablet. | Drug | Placebo and Rosuvastatin |
| Rosuvastatin (Inhibitor arm)Also: CrestoRosuvastatin will be administered as follows: Day 8: single dose of 10 mg Rosuvastatin tablet. | Drug | Eltrombopag and Rosuvastatin |
| EltrombopagAlso: PromactaEltrombopag will be administered as follows: Day 8: single dose of 75 mg Eltrombopag tablet. | Drug | Eltrombopag and Rosuvastatin |
Primary outcome
Composite of pharmacokinetics of co-administration of rosuvastatin and eltrombopag in healthy volunteers.
Time frame: 24 and 72 hours
Mean difference in area under the curve (AUC) between rosuvastatin 10mg + placebo versus rosuvastatin 10mg + eltrombopag 75mg
Composite of pharmacokinetics of co-administration of rosuvastatin and eltrombopag in healthy volunteers.
Time frame: 24 hour
Mean difference in Cmax between rosuvastatin 10mg + placebo versus rosuvastatin 10mg + eltrombopag 75mg
1 secondary outcome
Composite of BCRP biomarkers of co-administration of rosuvastatin and eltrombopag in healthy volunteers.
Time frame: 24 and 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Giacomini, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rosuvastatin, Rosuvastatin (Inhibitor arm) and Eltrombopag in people with Healthy Volunteers, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of pharmacokinetics of co-administration of rosuvastatin and eltrombopag in healthy volunteers. (time frame: 24 and 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.