Healthy Volunteers
Conditions
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 similar to the capsule formulation over the dose range that may be used in future clinical studies, evaluate the effect of food on the bioavailability of branebrutinib from a tablet formulation at a dose projected to provide similar pharmacokinetics (PK) as the 9 mg capsule formulation, and evaluate the safety and the PK of multiple oral dose of tablet formulation of branebrutinib in healthy participants.
Interventions
DRUGBranebrutinib
Specified dose on specified days
DRUGPlacebo
Specified Dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to 30 days post last scheduled visit |
| Number of participants with vital sign abnormalities | Up to Day 14 |
| Maximum observed plasma concentration (Cmax) | Up to Day 14 |
| Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 14 |
| AUC from time zero extrapolated to infinite time (AUC(INF)) | Up to Day 14 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 14 |
| Number of participants with physical examination abnormalities | Up to Day 14 |
| Number of participants with clinical laboratory abnormalities | Up to Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 14 |
| Geometric mean ratio of Cmax | Up to Day 17 |
| Number of participants with clinical laboratory abnormalities | Up to Day 14 |
| Number of participants with physical examination abnormalities | Up to Day 14 |
| Geometric mean ratio of AUC(0-T) | Up to Day 17 |
| Geometric mean ratio of AUC(INF) | Up to Day 17 |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 17 |
| Apparent total body clearance (CLT/F) | Up to Day 14 |
| Apparent volume of distribution (Vz/F) | Up to Day 14 |
| Number of participants with AEs | Up to 30 days post last scheduled visit |
| Number of participants with vital sign abnormalities | Up to Day 14 |
Countries
United States
Outcome results
None listed