NCT04515628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2020

Completed
Last Updated

March 10, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

August 14, 2020

Last Update Submit

February 25, 2022

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (14)

  • 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

  • +9 more secondary outcomes

Study Arms (4)

Period A: Rosuvastatin

EXPERIMENTAL
Drug: Rosuvastatin

Period B: Branebrutinib

EXPERIMENTAL
Drug: Branebrutinib

Period C: Branebrutinib + Rosuvastatin and Branebrutinib

EXPERIMENTAL
Drug: RosuvastatinDrug: Branebrutinib

Period D: Branebrutinib

EXPERIMENTAL
Drug: Branebrutinib

Interventions

RosuvastatinDRUG

Specified dose on specified days

Period A: RosuvastatinPeriod C: Branebrutinib + Rosuvastatin and Branebrutinib
BranebrutinibDRUG

Specified dose on specified days

Period B: BranebrutinibPeriod C: Branebrutinib + Rosuvastatin and BranebrutinibPeriod D: Branebrutinib

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON (LPRA) - Salt Lake

Salt Lake City, Utah, 84124, United States

Location

Related Links

MeSH Terms

Interventions

Rosuvastatin Calciumbranebrutinib

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 17, 2020

Study Start

August 2, 2020

Primary Completion

October 18, 2020

Study Completion

October 26, 2020

Last Updated

March 10, 2022

Record last verified: 2022-02

Locations

US(1)