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Completed

NCT Number: NCT04515628

Study to Assess the Effect of Branebrutinib on the Drug Levels 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.

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Key information

Conditions

Healthy Participants

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON (LPRA) - Salt Lake

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Specified dose on specified days

Branebrutinib

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of rosuvastatin

    Time frame: Up to 6 days

  2. Maximum observed plasma concentration (Cmax) of rosuvastatin when coadministered with branebrutinib

    Time frame: Day 13

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Day 13

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 33 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 77 days

  3. Incidence of AEs leading to discontinuation

    Time frame: Up to 33 days

  4. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 54 days

  5. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 54 days

  6. Incidence of clinically significant changes in vital signs: Blood pressure

    Time frame: Up to 54 days

  7. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 54 days

  8. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 53 days

  13. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Time frame: Up to 53 days

  14. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Time frame: Up to 53 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2020
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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