Clinical trial · Interventional
Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP)
Identification and Validation of Biomarkers for Breast Cancer Resistance Protein
NCT04542382CI-TRIAL-00087858BCRPmarkercompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Volunteers | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eltrombopag | Drug | — | UNRESOLVED |
| Rosuvastatin | Drug | — | UNRESOLVED |
| Rosuvastatin (Inhibitor arm) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Placebo and Rosuvastatin
- description
- Subjects will be dosed with placebo tablet and Rosuvastatin 10mg tablet
- interventionNames
- Drug: Rosuvastatin
- type
- EXPERIMENTAL
- label
- Eltrombopag and Rosuvastatin
- description
- Subjects will be dosed with Eltrombopag 75mg tablet and Rosuvastatin 10mg tablet
- interventionNames
- Drug: Rosuvastatin (Inhibitor arm)
- Drug: Eltrombopag
Primary outcomes (2)
- measure
- Composite of pharmacokinetics of co-administration of rosuvastatin and eltrombopag in healthy volunteers.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.