Clinical trial NCT05303220: 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
Official title: A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Bioavailability of Branebrutinib in a Tablet Formulation Relative to Branebrutinib (RBA) in a Capsule Formulation Including the Effect of Food (Low-fat/Low-calorie and a High-fat/High-calorie) on the Bioavailability of Branebrutinib From a Tablet Formulation and a Double-blind Study to Evaluate the Safety and Pharmacokinetics of Branebrutinib From a Tablet Formulation in a Multiple-dose Arm in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/exclusion criteria apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 14
measure: Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to Day 14
measure: AUC from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to Day 14
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 30 days post last scheduled visit
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 14
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 14
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 14
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 14
Secondary outcomes:
measure: Geometric mean ratio of Cmax
timeFrame: Up to Day 17
measure: Geometric mean ratio of AUC(0-T)
timeFrame: Up to Day 17
measure: Geometric mean ratio of AUC(INF)
timeFrame: Up to Day 17
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to Day 17
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to Day 14
measure: Apparent volume of distribution (Vz/F)
timeFrame: Up to Day 14
measure: Number of participants with AEs
timeFrame: Up to 30 days post last scheduled visit
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 14
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 14
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 14
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 14
Other outcomes:
Locations:
city: Miami
country: United States
facility: Local Institution - 0001
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: