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NCT04515628 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT04515628 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 22 participants.
The verdict
NCT04515628, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the interaction of branebrutinib with rosuvastatin. Rosuvastatin is a substrate of the breast cancer resistance protein (BCRP) transporter, which has a drug level profile that can be markedly altered by coadministration of known inhibitors of the BCRP transporter. With widespread use of statins as cholesterol-lowering agents, rosuvastatin is also a likely concomitant drug for participants who would potentially be treated with branebrutinib.
Interventions
- DRUG Rosuvastatin
- DRUG Branebrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-08-02 |
| Est. Completion | 2020-10-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04515628
The ClinicalTrials.gov registry entry for NCT04515628 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rosuvastatin is the first listed.
NCT04515628 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04515628 about?
NCT04515628 is a clinical study titled "Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants". The purpose of this study is to examine the interaction of branebrutinib with rosuvastatin. Rosuvastatin is a substrate of the breast cancer resistance protein (BCRP) transporter, which has a drug level profile that can be markedly altered by coadministration of known inhibitors of the BCRP transpor...
What is the current status of trial NCT04515628?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2020-08-02. Estimated completion is 2020-10-26.
What interventions are being tested in trial NCT04515628?
The interventions under investigation include: Rosuvastatin (DRUG), Branebrutinib (DRUG).
Who is sponsoring clinical trial NCT04515628?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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