Phase 1 - To Assess PK of AZD4831 with Rifampicin

• 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 Rifampicin

• IRAS ID

  306940

• Contact name

  David Steel

• Contact email

  David.Steel@parexel.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2021-005695-19

• Duration of Study in the UK

  0 years, 2 months, 14 days

• Research summary

  This is an open-label, fixed sequence study in healthy subjects, performed at a single study centre in up to 14 healthy male and female volunteers.
  The main purpose of the clinical trial is to investigate whether Rifampicin 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 rifampicin, a registered drug, activates 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 rifampicin.
  An optional blood sample might be collected to investigate certain genes that may be related to how AZD4831 is metabolised by the subject’s body and/or to the development of skin reactions.
  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 12 to 14. On Days 8 to 12 and 15 to 19, outpatient dosing with rifampicin 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: 600 mg rifampicin (2 capsules of 300 mg) only (Days 8 to 12)
  o Treatment Period 3: 5 mg AZD4831 plus 600 mg rifampicin (Day 13) followed by 600 mg rifampicin only (Days 14 to 19)
  • A final Follow-up Visit on of the days in between Day 23 to Day 27.
  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
  

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  21/LO/0797

• Date of REC Opinion

  5 Jan 2022

• REC opinion

  Further Information Favourable Opinion