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

NCT04515628 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-03-10

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

Rosuvastatin

Specified dose on specified days

DRUG

Branebrutinib

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-02
Primary Completion
2020-10-18
Completion
2020-10-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515628 on ClinicalTrials.gov