A single and multiple ascending dose study to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD2389 in healthy participants

Exclusion Criteria

• • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• • History of chronic haematologic disease.
• • Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
• • Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results
• • Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg), hepatitis C antibody and Human immunodeficiency virus (HIV).
• • Any clinically important abnormalities in rhythm, conduction or morphology of the resting Electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
• • Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the investigator or any participant (male or female) who consumes more than one standard alcoholic drink per day on a regular basis in the 6 months prior to screening and as judged by the investigator (a standard drink is defined as 12 fl oz of beer, 5 fl oz of wine or 1.5 fl oz of distilled spirits), ), and/or a positive screen for alcohol at Screening or on each admission to the Clinical Unit.
• • Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the previous 3 months.
• • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2389.
• • Excessive intake of caffeine containing drinks or food
• • 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 nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen [up to 2 g/day]), herbal remedies, mega dose vitamins (intake of > 20 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.
• • Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
• • History of coagulation or bleeding disorders or use of anti-platelets/anti-coagulants during the 3 months prior to the Screening Visit, as judged by the investigator.
• • History of hypersensitivity as judged by the investigator, to drugs with a similar chemical structure or class.
• • History of severe dermatological disorders, eg, bullous pemphigoid or Stevens-Johnson syndrome, or clinically significant new or healing wounds in areas of the body not always covered by clothing such as face, forearm, and lower leg, as judged by the investigator.