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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: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.

NCT04515628 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 22 participants
Start Date 2020-08-02
Est. Completion 2020-10-26
Phase Phase 1
Bristol-Myers Squibb

1,025 total trials

What the finished NCT04515628 record still lists

NCT04515628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 2 interventions - of which Rosuvastatin is the first listed.

NCT04515628 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04515628's enrollment target sits among peer trials

22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04515628, the US trial registry maintained by the National Library of Medicine. NCT04515628 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.