Status:
COMPLETED
A Study to Assess Relative Bioavailability of Branebrutinib, From a Tablet Formulation to the Capsule Formulation, the Effect of Food on the Bioavailability of Branebrutinib From a Tablet Formulation, and the Safety and Drug Levels of Branebrutinib From a Tablet Formulation in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the relative bioavailability of branebrutinib tablet formulation relative to the capsule formulation in order to identify doses that would provide exposures simi...
Eligibility Criteria
Inclusion
- Healthy male and female participants, of any race, as determined by no deviation considered significant by the investigator from normal in medical history, physical examination, 12-lead ECG measurements, and clinical laboratory determinations at screening or at check-in
- Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height \[m\])2 for participants
- Participant is afebrile (febrile is defined as ≥ 38°C or ≥100.4°F), with systolic blood pressure ≥ 90 and ≤ 160 mm Hg, diastolic blood pressure ≥ 50 and ≤ 100 mm Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute at screening
Exclusion
- 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
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases
- History of acute or chronic bacterial, fungal, or viral infection necessitating treatment or inpatient admission within the 3 months prior to screening, or active/symptomatic infection at the time of screening
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05303220
Start Date
April 8 2022
End Date
August 18 2022
Last Update
February 15 2023
Active Locations (1)
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1
Local Institution - 0001
Miami, Florida, United States, 33136