Study to Assess Bioavailability and Food Effect on AZD9833 (QSC203725)
Research type
Research Study
Full title
A Randomised, Open-Label Study to Determine the Relative Bioavailability of Different Oral AZD9833 Tablet Formulations and an AZD9833 Oral Solution, the Effect of Food on the Pharmacokinetics of an Oral AZD9833 Tablet Formulation, and the Absolute Bioavailability of AZD9833 Following Co-Administration of an Oral AZD9833 Tablet Formulation with a Single Radiolabelled Intravenous Microdose of [14C]AZD9833, in Healthy Post-Menopausal Female Subjects at Two Dose Levels
IRAS ID
282695
Contact name
Maria Nieto-Gutierrez
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-002280-66
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 13 days
Research summary
Research Summary:
The Sponsor is developing the test medicine, AZD9833, for the potential treatment of oestrogen receptor (ER) positive breast cancer. ER-positive breast cancer is where the cancer cells grow in response to the hormone oestrogen.The study will try to identify and compare how much of the test medicine formulations (recipes) are taken up into the blood when given as a tablet, a solution and as an injection directly into the vein. The dose given directly into the vein will be radiolabelled, meaning that it contains a radioactive component in order to track where the drug is in the body. This study will also look at the effect of food when taking the test medicine in the form of the tablet. The test medicine safety and tolerability will also be assessed.
This is a one-part study involving up to 32 healthy post-menopausal female volunteers aged 50 to 70. Volunteers will be randomly assigned to a group of up to 8, two groups will partake in four study periods and two groups will partake in three study periods. Volunteers will be admitted to the clinical unit on the day before dosing (Day -1) for each study period. On Day 1 of each study period, volunteers will receive either a single oral dose (tablet or solution) of AZD9833 or a single oral dose (tablet) of AZD9833 co-administered with a single radiolabelled IV dose of [14C]AZD9833, in either the fed or fasted state. There will be a minimum 7 day washout between periods.
Volunteers will remain resident until 72 hours post dose (Day 4) of each study period. A follow-up phone call will take place 5 to 7 days post-final dose to ensure the ongoing wellbeing of the volunteers.
Summary of Results:
Overall, researchers found that taking AZD9833 (the active ingredient of the test medicine) as either a tablet at 2 different doses or as a liquid by mouth did not affect how much AZD9833 got into the participants’ blood. In addition, the researchers found that taking either a low or a high dose of AZD9833 after not eating or after eating did not affect how much AZD9833 got into the participants’ blood.REC name
Wales REC 2
REC reference
20/WA/0159
Date of REC Opinion
11 Jun 2020
REC opinion
Favourable Opinion