A study to Assess the Pharmacokinetics of AZD4831 when Administered Alone and in Combination with Itraconazole

Exclusion Criteria

• • History of any clinically significant disease or disorder, including hyperthyroidism, uncontrolled hypothyroidism or any clinically significant thyroid disease.
• • 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).
• • A positive COVID-19 test at the Screening Visit or admission to the Clinical Unit.
• • Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis, vital signs, and 12-lead ECG.
• • Any positive result at the Screening Visit for serum Hepatitis B surface antigen (HBsAg), HCV, and Human immunodeficiency virus (HIV) antibody.
• • Known or suspected Gilbert’s syndrome.
• • Known or suspected history of drug abuse in the last 2 years, as judged by the Investigator.
• • Has received another new chemical or biological entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study or final follow up visit within 1 month of 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 the Screening Visit.
• • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4831 or itraconazole.
• • Current smokers or those who have smoked or used nicotine products (including e cigarettes).
• • Excessive intake of caffeine-containing drinks or foods.
• • Known or suspected history of alcohol or excessive intake of alcohol.
• • Positive screen for drugs of abuse or cotinine at screening.
• • 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 COVID-19 vaccines, antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life.
• • Subjects who have previously received AZD4831.
• • Subjects who are lactose intolerant or have other specific dietary restrictions that cannot be accommodated by the Clinical Unit.
• • Subjects who, in the opinion of the Investigator, have any clinically significant skin condition.