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

An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State Branebrutinib on the Pharmacokinetics 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 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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Branebrutinib; Drug: Rosuvastatin

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period A: Rosuvastatin	Drug: Rosuvastatin; Specified dose on specified days
Experimental: Period B: Branebrutinib	Drug: Branebrutinib; Specified dose on specified days
Experimental: Period C: Branebrutinib + Rosuvastatin and Branebrutinib	Drug: Branebrutinib; Specified dose on specified days; Drug: Rosuvastatin; Specified dose on specified days
Experimental: Period D: Branebrutinib	Drug: Branebrutinib; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs)		Up to 33 days
Incidence of Serious Adverse Events (SAEs)		Up to 77 days
Incidence of AEs leading to discontinuation		Up to 33 days
Incidence of clinically significant changes in vital signs: Body temperature		Up to 54 days
Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 54 days
Incidence of clinically significant changes in vital signs: Blood pressure		Up to 54 days
Incidence of clinically significant changes in vital signs: Heart rate		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	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	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	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)	Up to 54 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 53 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 53 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 53 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2020
• Primary Completion (Actual): October 18, 2020
• Study Completion (Actual): October 26, 2020

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Protein Kinase Inhibitors; Rosuvastatin Calcium; Branebrutinib
• Other Study ID Numbers: IM014-032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No