AstraZeneca AB 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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Dose of \[14C\]AZD9833 Solution for Infusion
Dose 1 AZD9833 film-coated tablet A Dose 1
AZD9833 Oral Solution
AZD9833 film-coated tablet B Dose 1
Dose 1 of AZD9833 film-coated tablet A Dose 2
Dose 1 of film-coated tablet B Dose 2
Research Site
Ruddington, United Kingdom
Relative bioavailability of AZD9833 based on Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)
Assessment of the PK (pharmacokinetics) on AZD9833 by measuring relative bioavailability based on AUC0-t
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose
Relative bioavailability of AZD9833 based on area under the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf)
Assessment of the PK (pharmacokinetics) on AZD9833 by measuring relative bioavailability based on AUC0-inf
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose
Relative bioavailability of AZD9833 based on Maximum observed concentration (Cmax)
Assessment of the PK (pharmacokinetics) on AZD9833 by measuring relative bioavailability based on Cmax
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose
Area under the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf) for AZD9833 vs [14C]-AZD9833 and total radioactivity
Assessment of AZD9833 and total radioactivity by measuring the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf)
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose
Number of adverse events (AE) experienced by subjects
Safety and tolerability assessed through the incidence of AEs
Time frame: AEs recorded from the time of informed consent until discharge from the study (72 hours post-dose)
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