| Eligibility |
Inclusion Criteria:
- Capable of giving signed informed consent.
- Male participants and their female partners/spouses must adhere to the contraception
methods.
- Female participants must have a negative pregnancy test at screening, must not be
lactating, and must be of non-childbearing potential, confirmed at screening by
fulfilling one of the following criteria:
- Postmenopausal defined as amenorrhea for at least 12 months following cessation
of all exogenous hormonal treatments and follicle stimulating hormone levels in
the postmenopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral
oophorectomy, or bilateral salpingectomy but not bilateral tubal ligation.
- Have a body mass index between 18.5 and 30 kg/m^2, inclusive, and weigh at least 50 kg
and no more than 100 kg, inclusive, at screening.
- Understands the study procedures in the informed consent form and willing and able to
comply with the protocol.
Exclusion Criteria:
- History or presence of any clinically significant disease (including active
coronavirus disease 2019 infection).
- 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 investigational medicinal product (IMP).
- Any clinically significant abnormalities in hematology, coagulation, clinical
chemistry, or urinalysis results, at screening defined as:
- Hemoglobin less than lower limit of normal.
- Serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase
or serum bilirubin (total and direct) > 1.5 upper limit of normal.
- Any clinically significant abnormal findings in vital signs at screening (eg, systolic
blood pressure [BP] < 90 mmHg or = 140 mmHg; diastolic BP < 50 mmHg or = 90 mmHg;
pulse < 50 or > 90 bpm).
- Any clinically significant abnormalities on standard 12-lead electrocardiogram at
screening.
- Any positive result on screening for serum Hepatitis B surface antigen, hepatitis B,
hepatitis C, and Human immunodeficiency virus antibody.
- Has received a new chemical entity within 90 days of the first administration of IMP
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.
- Plasma donation within 30 days of screening or any blood donation/loss more than 500
mL during the 90 days prior to screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or
history of hypersensitivity to drugs with a similar chemical structure or class to
acalabrutinib or rabeprazole.
- Current smokers or those who have smoked or used nicotine products within the 90 days
prior to screening.
- Positive screen for drugs of abuse or cotinine at screening.
- Treatment with a strong cytochrome P450 3A (CYP3A) inhibitor (within 14 days before
first administration of IMP) or strong CYP3A inducer (within 28 days before first
administration of IMP).
- 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 IMP or longer if the medication has a long half-life.
Hormonal replacement therapy will not be allowed.
- Known or suspected history of alcohol or drug abuse, or excessive intake of alcohol.
- Excessive intake of caffeine-containing drinks or food or would likely be unable to
refrain from the use of caffeine-containing beverages during in-house stay at the
Clinical Unit.
- Involvement of any AstraZeneca, Acerta Pharma, Parexel or study site employee or their
close relatives.
- Judgment by the Investigator that the participant should not participate in the study
if they have any ongoing or recent (ie, during the screening period) minor medical
complaints that may interfere with the interpretation of study data or are considered
unlikely to comply with study procedures, restrictions, and requirements.
- Participants who cannot communicate reliably with the Investigator.
- Vulnerable participants, eg, kept in detention, protected adults under guardianship,
trusteeship, or committed to an institution by governmental or juridical order.
- Inability to swallow acalabrutinib capsules.
- Evidence of ongoing systemic bacterial, fungal, or viral infection (including upper
respiratory tract infections). Note: Participants with localized cutaneous fungal
infections are eligible.
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