Phase 1 DDI trial - to assess PK of AZD9833 with Itraconazole in healthy post-menopausal women

• Research type

  Research Study

• Full title

  An Open-Label, Fixed Sequence Study in Healthy Post Menopausal Female Subjects to Assess the Pharmacokinetics of Camizestrant (AZD9833) when Administered Alone and in Combination with Itraconazole

• IRAS ID

  1005901

• Contact name

  Tania Veiga

• Contact email

  tania.veiga@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2022-002011-35

• Clinicaltrials.gov Identifier

  NCT05551897

• Research summary

  The trial is a single centre, open label trial in up to 14 healthy post-menopausal female participants aged 50-70 years old.

  The medicine to be tested is this trial is called Camizestrant (AZD9833). The sponsor is developing the medicine for the treatment of women with estrogen receptor (ER)-positive breast cancer. Cells of this type of breast cancer have receptors that allow them to use the hormone estrogen to grow. Camizestrant (AZD9833) works by degrading and blocking these receptors and in this way stopping the growth of the cancer cells.
  Itraconazole is used to treat fungal infections. It is being used in this trial to determine if certain drugs like itraconazole can have an effect on how the body breaks down Camizestrant (AZD9833).

  The main purpose of the clinical trial is to investigate whether itraconazole affects how Camizestrant (AZD9833) is taken up, metabolised (chemically broken down), distributed through the body, and cleared from the body (referred to as pharmacokinetics or PK).
  The clinical trial will also assess how safe AZD9833 is and how well it is tolerated when given alone and in combination with itraconazole.
  The trial will comprise of:
  - A screening period of a maximum 28 days
  - Three dosing periods during which participants will be resident from the day before first dosing (Period 1/Day 1) until Day 4 in period 1, as well from the day before second dosing (Period 2/Day 1) until Day 4 of period 3.
  - A final Follow up visit 7-14 days after last PK sample
  The doses are as follows:
  -Period 1: Day 1: 75 mg AZD9833 (1 tablet of 75 mg)
  -Period 2: Day 1: 400 mg itraconazole (2 capsules of 200 mg). Day 2 and 3: 200 mg itraconazole (1 capsule of 200 mg)
  -Period 3: Day 1: 75 mg AZD9833 (1 tablet of 75 mg) and 200 mg itraconazole (1 capsule of 200 mg). Day 2 and 3: 200 mg itraconazole (1 capsule of 200 mg)
  This is not a first-in-human trial as the study medication has been given to humans before in clinical trials.

  Lay Summary:
  https://www.trialsummaries.com/Study/StudyDetails?uniqueStudyId=D8532C00003&tenant=MT_MED_9011

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  22/LO/0449

• Date of REC Opinion

  28 Sep 2022

• REC opinion

  Further Information Favourable Opinion