A study to assess the effect of fluvoxamine and smoking on pharmacokinetics ( the movement of drugs within the body) of AZD4635 in healthy volunteers

Exclusion Criteria

• -History of any clinically significant disease or disorder which, in the opinion of the principal investigator (PI), 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.
• -History of cardiac disease; concurrent electroconvulsive therapy, diabetes mellitus, epilepsy, bleeding disorders (especially GI bleeding), mania and susceptibility to angle-closure glaucoma.
• -Presence of refractory nausea and vomiting or chronic GI diseases.
• -Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
• -Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the PI (based on laboratory parameters).
• -Any clinically significant abnormal findings in vital signs at screening as judged by the PI.
• -Systolic blood pressure (BP) >140 and/or diastolic BP > 90 mmHg, or history of hypertension at screening.
• -Any confirmed clinically significant abnormalities on 12-lead ECG at screening, as judged by the PI.
• -Haemoglobin A1c (HbA1c) >5.7% at the screening visit.
• -Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibodies.
• -Known or suspected history of drug abuse, within the past 2 years, as judged by the PI.
• -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.
• -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 PI.
• -Positive screen for drugs of abuse at screening or admission to the study centre.
• -Use of herbal preparations/medications within 14 days prior to the administration of the first dose of AZD4635.
• -Subject who has had prescription or non-prescription drugs or other products known to be sensitive to Breast cancer resistance protein.
• -Use of any prescribed or non prescribed medication including antacids, analgesics, 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.
• -Subjects who have involvement with AstraZeneca or Parexel or are study site employee or their close relatives.
• -Subjects who have previously been enrolled in this study or have previously received AZD4635.
• -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.