Phase 1 trial assessing PK of AZD9833 with Midazolam & Carbamazepine in healthy postmenopausal women
Research type
Research Study
Full title
A Phase I, Open-label, 2 Part, Fixed Sequence Study to Assess the Effect of Co-administration of Camizestrant (AZD9833) on the Pharmacokinetics of Midazolam Exposure (CYP3A4/5 Substrate) and of Carbamazepine (CYP3A4/5 Inducer) on Camizestrant Exposure in Healthy Post-Menopausal Female Participants
IRAS ID
1010054
Contact name
Maria Nieto-Gutierrez
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
This is a single centre, open-label trial in up to 40 healthy post-menopausal females (of non-childbearing potential) between the ages of 50-70 years. The trial has two parts: Part A - 22 female participants and Part B - 18 female participants. The investigational medicine being tested is Camizestrant (AZD9833), developed for treating Breast Cancer by degrading and blocking estrogen receptors in cancer cells.
Part A investigates how Midazolam (a medicine that helps to relieve anxiety) is taken up and metabolised (chemically broken down) by the body, when given together with the clinical trial medicine (Camizestrant/AZD9833). The clinical trial will also see how safe the clinical trial medicine is and how well it is tolerated after dosing with Midazolam.
Part A consists of:
• Screening - 28 days
3 Treatment Periods:
• Period 1 - Day1 (Single oral dose of 1mg Midazolam)
• Period 2 - Days 2-6 (75mg oral dose of Camizestrant)
• Period 3 - Days 7-8 (Single oral dose of 1mg Midazolam co-dosed with single oral dose of 75mg Camizestrant on Day 7)
• Safety follow up visit 7±2 days after last PK sample.Duration - 7 weeks.
Part B investigates how the clinical trial medicine is taken up and metabolised by the body when taking another drug called Carbamazepine, which is an anti-convulsant medicine. The clinical trial will also see how safe the clinical trial medicine (Camizestrant/AZD9833) is and how well it is tolerated after dosing with Carbamazepine.
Part B consists of:
• Screening 28 days
2 Treatment Periods:
• Period 1 – Day 1 (Single oral dose of 75mg Camizestrant)
• Period 2 - Days 4-6 (Low oral dose 100mg Carbamazepine)
• Days 7-9 (Titrated mid oral dose 200mg Carbamazepine
Days 10-24 High oral dose 300mg of Carbamazepine
• Single oral dose of 75mg Camizestrant on Day 22
• Safety follow-up visit 7±2 days after last PK sample.Duration - 9 weeks.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0395
Date of REC Opinion
29 Jul 2024
REC opinion
Further Information Favourable Opinion