A Study to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole

• Status: Not yet recruiting
• Trial end date: 2022-04-27
• Target enrollment: 0
• Participant gender: All

Summary

A study to demonstrate pharmacokinetics of AZD4831 when administered alone and in combination with Itraconazole.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Parexel
• Treatments: Itraconazole

Criteria

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures.

• Healthy male and female (non-childbearing potential) subjects aged 18 to 55 years (inclusive) at the time of signing informed consent, with suitable veins for cannulation or repeated venepuncture.

• Males must be willing to use appropriate contraception methods.

• Females must not be lactating and must be of non-childbearing potential.

• Have a .BMI between 18.5 and 30.0 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive) at Screening.

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.