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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04515628
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 4
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 7.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: Rosuvastatin; Drug: Branebrutinib	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 2, 2020
• Actual Primary Completion Date: Oct 18, 2020
• Actual Study Completion Date: Oct 26, 2020

Arms and Interventions

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: Rosuvastatin; Specified dose on specified days; Drug: Branebrutinib; Specified dose on specified days
Experimental: Period D: Branebrutinib	Drug: Branebrutinib; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) of rosuvastatin [Up to 6 days]

2. Maximum observed plasma concentration (Cmax) of rosuvastatin when coadministered with branebrutinib [Day 13]

3. Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin [Up to 6 days]

4. Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin when coadministered with branebrutinib [Day 13]

5. 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]

6. 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

1. Incidence of Adverse Events (AEs) [Up to 33 days]

2. Incidence of Serious Adverse Events (SAEs) [Up to 77 days]

3. Incidence of AEs leading to discontinuation [Up to 33 days]

4. Incidence of clinically significant changes in vital signs: Body temperature [Up to 54 days]

5. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 54 days]

6. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 54 days]

7. Incidence of clinically significant changes in vital signs: Heart rate [Up to 54 days]

8. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [Up to 54 days]

   PR interval: The time from the onset of the P wave to the start of the QRS complex

9. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [Up to 54 days]

   QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization

10. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [Up to 54 days]

    QT interval: Measured from the beginning of the QRS complex to the end of the T wave

11. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [Up to 54 days]

    QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)

12. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 53 days]

13. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Up to 53 days]

14. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 53 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICON (LPRA) - Salt Lake	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04515628
• Other Study ID Numbers: IM014-032
• First Posted: Aug 17, 2020
• Last Update Posted: Mar 10, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rosuvastatin Calcium; Branebrutinib

Study Results

No Results Posted as of Mar 10, 2022