Status:
COMPLETED
A Study to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A study to demonstrate pharmacokinetics of AZD4831 when administered alone and in combination with Itraconazole.
Detailed Description
This will be a an open-label, 3-period fixed sequence study to be conducted at a single study centre. The treatment starts with AZD4831 (Treatment Period 1), followed by Itraconazole administration f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05236543
Start Date
February 18 2022
End Date
August 12 2022
Last Update
August 23 2022
Active Locations (1)
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1
Research Site
Harrow, United Kingdom, HA1 3UJ