A study to assess the drug absorption into the blood after administration of 3 doses of AZD5718

Exclusion Criteria

• • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer’s ability to participate in the study.
• • History or presence of gastrointestinal (GI), 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 IMP.
• • Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at the Screening Visit and/or admission to the Clinical Unit (Day -1), as judged by the Investigator including:
• o Alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN).
• o Aspartate aminotransferase (AST) >1.5 x ULN.
• o Bilirubin (total) >1.5 x ULN.
• o Gamma glutamyl transpeptidase (GGT) >1.5 x ULN.
• • Any clinically significant abnormal findings in vital signs at the Screening Visit and/or admission to the Clinical Unit (Day -1), as judged by the Investigator.
• • Any clinically significant abnormalities on 12 lead ECG at the Screening Visit, as judged by the Investigator.
• • Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
• • Known or suspected history of drug abuse, as judged by the Investigator.
• • Known or suspected Gilbert’s syndrome.
• • Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the Investigator.
• • Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the 3 administration of IMP in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest. Note: subjects consented and screened, but not randomized in this study or a previous Phase I study, are not excluded.
• • Plasma donation within 1 month of the Screening Visit or any blood donation/loss more than 500 mL during the 3 months prior to the Screening Visit.
• • 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 AZD5718.
• • Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to the Screening Visit.
• • Excessive intake of caffeine containing drinks or food (eg, coffee, tea, chocolate,) as judged by the Investigator.
• • Positive screen for drugs of abuse, alcohol or cotinine at the Screening Visit or on admission to the Clinical Unit.
• • Use of drugs with enzyme-inducing properties such as St John’s Wort within 3 weeks prior to the 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 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
• • Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.
• • Subjects who have previously received AZD5718.
• • Judgment by the Investigator that the subject 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.
• • Vulnerable subjects, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.