Study to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule

Exclusion Criteria

• • History or presence of any clinically significant disease (including active coronavirus disease 2019 [COVID-19] infection) or disorder
• • History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
• • Any clinically significant illness, medical/surgical procedure, or trauma within 30 days of the first administration of study drug
• • Any clinically significant abnormalities in hematology, coagulation, clinical chemistry, or urinalysis results, at Screening and prior to first dose, as judged by the Investigator and defined as:
• (i) Hemoglobin less than lower limit of normal
• (ii) Absolute neutrophils less than lower limit of normal
• (iii) Platelets less than lower limit of normal
• (iv) Serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase or serum bilirubin (total bilirubin and direct bilirubin) > upper limit of normal
• • Any clinically significant abnormal findings in vital signs at Screening or on Day 1 (eg, systolic BP < 90 mmHg or > 140 mmHg; diastolic BP < 50 mmHg or > 90 mmHg; pulse < 45 or > 90 bpm)
• • Any clinically significant abnormalities on standard 12-lead ECG at Screening or on Day 1
• • Any positive result for HBsAg, hepatitis C antibody, and HIV testing, at Screening
• • Has received a new chemical entity (defined as a compound which has not been approved for marketing) within 90 days of the first administration of study drug in this study. The period of exclusion begins 90 days after the final dose or 30 days after the last visit whichever is the longest
• • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to acalabrutinib
• • Positive screen for drugs of abuse or cotinine and alcohol, at Screening and on admission to the study center
• • Treatment with prescription or non-prescription drugs or other products known to be strong CYP3A, P-gp, or breast cancer resistance protein (BCRP) inhibitors or substrates of BCRP or MATE1 (within 14 days before first administration of study drug or longer if the medication has a long half life) and strong CYP3A inducers (within 28 days before first administration of study drug or longer if the medication has a long half life)
• • Use of any prescribed or non prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose), and minerals during the 14 days prior to the first administration of study drug or longer if the medication has a long half life
• • Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as judged by the Investigator
• • Inability to swallow acalabrutinib tablets or acalabrutinib capsules
• • Evidence of ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections)
• • Participant has a positive test result for severe acute respiratory syndrome coronavirus 2 reverse transcriptase polymerase chain reaction before randomization
• • Participant has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening or on admission
• • History of severe COVID-19 (hospitalization, extracorporeal membrane oxygenation, mechanically ventilated)
• • Participants who are regularly exposed to COVID-19 as part of their daily life (eg, health care professionals working in COVID-19 wards or at emergency departments)