A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (what does the body does to the drug) of Rosuvastatin to Measure the Relative Bioavailability (the extent to which a drug or other substance becomes available to the body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release Tablet

Exclusion Criteria

• Subjects will not enter the study if any of the following exclusion criteria are fulfilled:
• 1. History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
• 2. History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• 3. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
• 4. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at the Screening Visit and/or admission to the study unit as judged by the PI including: − Aminotransferase (ALT) > upper limit of normal (ULN); − Aspartate aminotransferase (AST) >
• ULN; − Total bilirubin (TBL) > ULN; and − Gamma glutamyl transpeptidase (GGT) > ULN.
• 5. Any clinically significant abnormal findings in vital signs at the Screening Visit and/or admission to the study unit, as judged by the PI defined as any of the following: − Systolic BP (SBP) < 90 mmHg or ≥ 140 mmHg; − Diastolic BP (DBP) < 50 mmHg or ≥ 90 mmHg; and − Pulse < 45 or > 85 beats per minute (bpm).
• 6. Any clinically significant abnormalities (at the Screening Visit and admission) in rhythm, conduction or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy.
• 7. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
• 8. Subjects with myopathy.
• 9. Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or 1 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.
• 10. 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.
• 11. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5718 and/or rosuvastatin.
• 12. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to the Screening Visit.
• 13. Positive screen for drugs of abuse or cotinine at the Screening Visit or on each admission to the study center or positive screen for alcohol on each admission to the study center.
• 14. Excessive intake of caffeine containing drinks or food (e.g., coffee, tea, chocolate), as judged by the investigator.
• 15. Use of drugs with enzyme-inducing properties such as St John’s Wort within 3 weeks prior to the first administration of IMP.
• 16. 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. Note: Hormonal replacement therapy is not allowed for females.
• 17. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI.
• 18. Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives. 19. Subjects who have previously received AZD5718.
• 20. Judgment by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., 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.
• 21. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order In addition, the following is considered a criterion for the exclusion from the optional genetic component of the study:
• 22. Previous bone marrow transplant.
• 23. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection or previous bone marrow transplant.