Clinical trial NCT04515628: Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-08-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of rosuvastatin
timeFrame: Up to 6 days
measure: Maximum observed plasma concentration (Cmax) of rosuvastatin when coadministered with branebrutinib
timeFrame: Day 13
measure: Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin
timeFrame: Up to 6 days
measure: Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin when coadministered with branebrutinib
timeFrame: Day 13
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin
timeFrame: Up to 6 days
measure: 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
timeFrame: Day 13
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 33 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 77 days
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 33 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 54 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 54 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 54 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 54 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
timeFrame: Up to 54 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
timeFrame: Up to 54 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
timeFrame: Up to 54 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
timeFrame: Up to 54 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 53 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to 53 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to 53 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON (LPRA) - Salt Lake
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: