Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants
NCT ID: NCT04515628
Last Updated: 2022-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2020-08-02
2020-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Period A: Rosuvastatin
Rosuvastatin
Specified dose on specified days
Period B: Branebrutinib
Branebrutinib
Specified dose on specified days
Period C: Branebrutinib + Rosuvastatin and Branebrutinib
Rosuvastatin
Specified dose on specified days
Branebrutinib
Specified dose on specified days
Period D: Branebrutinib
Branebrutinib
Specified dose on specified days
Interventions
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Rosuvastatin
Specified dose on specified days
Branebrutinib
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
50 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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ICON (LPRA) - Salt Lake
Salt Lake City, Utah, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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IM014-032
Identifier Type: -
Identifier Source: org_study_id
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