Phase 1 - To assess PK of AZD4831 with Itraconazole
Research type
Research Study
Full title
An Open-label, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of AZD4831 when Administered Alone and in Combination with Itraconazole
IRAS ID
306941
Contact name
David Steel
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-005727-21
Duration of Study in the UK
0 years, 2 months, 6 days
Research summary
Research Summary
This is an open-label, 3-period fixed sequence study in healthy subjects, performed at a single study centre in at least 12 healthy male and female volunteers.
The main purpose of the clinical trial is to investigate whether itraconazole affects how AZD4831 is taken up, metabolised (chemically broken down), distributed through the body, and cleared from the body (referred to as pharmacokinetics or PK). AZD4831 is broken down by the cytochrome CYP450 3A4 specific drug-degrading enzyme while itraconazole, a registered drug, inhibits this respective system.
The clinical trial will also assess how safe AZD4831 is and how well it is tolerated when given alone and in combination with itraconazole.
An optional blood sample might be collected to investigate certain genes that may be related to how AZD4831 is metabolised.
The study will comprise:
• A Screening Period of maximum 28 days;
• Three treatment periods during which volunteers will be resident from the day before first dosing (Day 1) until Day 2, as well as from Day 10 to 12. On Days 8 and 9 and 13 to 17, outpatient dosing with itraconazole will be performed.
The doses are as follows:
o Treatment Period 1: 5 mg AZD4831 (1 tablet of 5 mg) only (Day 1)
o Treatment Period 2: 400 mg itraconazole (2 capsules of 200 mg) only (Day 8), followed by 200 mg itraconazole only (1 capsule of 200 mg Days 9 and 10)
o Treatment Period 3: 5 mg AZD4831 plus 200 mg itraconazole (Day 11) followed by 200 mg itraconazole only (Days 12 to 17)
• A final Follow-up Visit on of the days in between Days 25 to 32.
This is not a first-in-human study as the study drug has been given to humans before in clinical studies. AZD4831 is being developed for the treatment of cardiovascular disease.Lay summary of study results
As per Sponsor SOPs the Lay Language summary should be posted within 2 years of LSLV, therefore this is not available at this time.REC name
London - Chelsea Research Ethics Committee
REC reference
21/LO/0798
Date of REC Opinion
5 Jan 2022
REC opinion
Further Information Favourable Opinion