CompletedNCT04515628Updated Mar 10, 2022

Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants

A Phase 1 interventional study of Rosuvastatin and Branebrutinib in Healthy Participants, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-10.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Oct 2020, 5 years 11 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 22
Allocation: Non-randomized
Ages: 18 Years to 50 Years
Sex: All

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.

Conditions studied

Healthy Participants

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

Inclusion Criteria:

Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations by investigator
Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, as measured at screening visit
Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion criteria

Exclusion Criteria:

Women who are of childbearing potential
Women who are pregnant or breastfeeding
Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study, including a history of or active liver disease
Any other sound medical, psychiatric, and/or social reason as determined by the investigator

Other protocol-defined inclusion/exclusion criteria apply

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 22 participants (actual)

Study arms

Experimental
Period A: Rosuvastatin
Drug: Rosuvastatin
Experimental
Period B: Branebrutinib
Drug: Branebrutinib
Experimental
Period C: Branebrutinib + Rosuvastatin and Branebrutinib
Drug: Rosuvastatin · Drug: Branebrutinib
Experimental
Period D: Branebrutinib
Drug: Branebrutinib

Interventions

DrugRosuvastatin
Specified dose on specified days
DrugBranebrutinib
Specified dose on specified days

What researchers measure

Primary outcomes

Maximum observed plasma concentration (Cmax) of rosuvastatin
Time frame: Up to 6 days
Maximum observed plasma concentration (Cmax) of rosuvastatin when coadministered with branebrutinib
Time frame: Day 13
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin
Time frame: Up to 6 days
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin when coadministered with branebrutinib
Time frame: Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin
Time frame: Up to 6 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin when coadministered with branebrutinib
Time frame: Day 13

Secondary outcomes

Incidence of Adverse Events (AEs)
Time frame: Up to 33 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 77 days
Incidence of AEs leading to discontinuation
Time frame: Up to 33 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 54 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 54 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 54 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval: The time from the onset of the P wave to the start of the QRS complex
Time frame: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Time frame: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Time frame: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Time frame: Up to 54 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 53 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 53 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 53 days

Study locations

1 site

ICON (LPRA) - Salt Lake
Salt Lake City, Utah 84124, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04515628
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Aug 17, 2020
Start date: Aug 2, 2020
Primary completion: Oct 18, 2020
Completion: Oct 26, 2020
Last update: Mar 10, 2022

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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