| Eligibility |
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific
procedures.
- Healthy male and female subjects aged 18 to 58 years with suitable veins for
cannulation or repeated venipuncture.
- Females must not be lactating and must be of non-childbearing potential, confirmed at
screening:
1. Postmenopausal defined as aged > 40 years and amenorrhea for at least 12 months
or more following cessation of all exogenous hormonal treatments and follicle
stimulating hormone levels in the postmenopausal range.
2. Documentation of irreversible/permanent surgical sterilization by hysterectomy,
bilateral oophorectomy or bilateral salpingectomy but not tubal ligation, at
least 6 months prior to screening.
- Male subjects must be vasectomized, at least 6 months prior to screening, with
documented post-procedural medical assessment of surgical success.
- Have a body mass index between 18.0 and 29.9 kg/m^2 (inclusive) for males and 18 to 32
kg/m^2 (inclusive) for females; and weigh at least 50 kg and no more than 100 kg
inclusive.
- Non-smoker, defined as a subject who has not smoked previously or who has discontinued
smoking.
Exclusion Criteria:
- History of any clinically significant disease 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 4
weeks of the first administration of investigational medicinal product (IMP).
- Any clinically significant abnormal findings in vital signs at screening and/or
admission to the study center.
- Clinically significant abnormalities in glucose metabolism defined by any of the
following:
1. Diagnosis of diabetes mellitus type I or II (irrespective of management).
2. Blood glucose value = 5.9 mmol/L after fasting for at least 8 hours, at screening
or on admission to study center.
3. Glycosylated hemoglobin > upper limit of normal (up to 6.2% [44 mmol/mol]).
- Any positive result on screening for serum hepatitis B surface antigen or antibody to
hepatitis B core antigen, hepatitis C antibody, and human immunodeficiency virus
antibody.
- Known or suspected history of drug abuse.
- Has received another new chemical entity within 3 months of the first administration
of IMP in this study.
- Plasma donation within 1 month of screening or any blood donation/loss more than 500
mL during the 3 months prior to screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as
judged by the Investigator or history of hypersensitivity to drugs with a similar
chemical structure or class to capivasertib, rabeprazole, or famotidine.
- Subjects who have previously received capivasertib.
- Subject has a positive test result for Severe acute respiratory syndrome coronavirus 2
reverse transcription polymerase chain reaction on admission.
- Subject has clinical signs and symptoms consistent with Coronavirus Disease 2019
(COVID-19) (eg, fever, dry cough, dyspnea, sore throat, anosmia/hyposmia, loss or
reduced taste, and 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).
- Subjects who are regularly exposed to the risk of COVID-19 infection as part of their
daily life (eg, health care professionals working in COVID-19 wards or at emergency
departments).
- Subjects who have had a COVID-19 vaccine within 3 weeks prior to screening or are
planning to get a COVID-19 vaccine during the study.
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