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

Date de début de l'étude : 8 avril 2022

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