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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515628
• Other study ID #: IM014-032
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2020
• Est. completion date: October 26, 2020

Study information

• Verified date: February 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 26, 2020
• Est. primary completion date: October 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Rosuvastatin
Specified dose on specified days
• Branebrutinib
Specified dose on specified days

Locations

Country	Name	City	State
United States	ICON (LPRA) - Salt Lake	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of rosuvastatin		Up to 6 days
Primary	Maximum observed plasma concentration (Cmax) of rosuvastatin when coadministered with branebrutinib		Day 13
Primary	Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin		Up to 6 days
Primary	Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin when coadministered with branebrutinib		Day 13
Primary	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
Primary	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	Incidence of Adverse Events (AEs)		Up to 33 days
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 77 days
Secondary	Incidence of AEs leading to discontinuation		Up to 33 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 54 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 54 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 54 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 54 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 53 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 53 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 53 days

External Links

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