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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Healthy Participants

Treatments

Drug: Branebrutinib
Drug: Rosuvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT04515628
IM014-032

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 4 patient groups

Period A: Rosuvastatin
Experimental group
Treatment:
Drug: Rosuvastatin
Period B: Branebrutinib
Experimental group
Treatment:
Drug: Branebrutinib
Period C: Branebrutinib + Rosuvastatin and Branebrutinib
Experimental group
Treatment:
Drug: Rosuvastatin
Drug: Branebrutinib
Period D: Branebrutinib
Experimental group
Treatment:
Drug: Branebrutinib

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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