A Study to Assess the Rel Bioavailability, Food Effect and Absolute Bioavailability on the Pharmacokinetics of AZD9833
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): [14C]AZD9833 Solution for Infusion, (NMT 22.8 kBq/5mL); AZD9833 film-coated tablet A Dose 1; AZD9833 Oral Solution; AZD9833 film-coated tablet B Dose 1; AZD9833 film-coated tablet A Dose 2; AZD9833 film-coated tablet B Dose 2
Intervention type(s): Radiation; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): [14C]AZD9833; AZD9833 film-coated tablet phase 1; AZD9833 film-coated tablet late phase; AZD9833 film-coated tablet phase 1; AZD9833 film-coated tablet late phase
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oestrogen receptor (ER) positive breast cancer; breast cancer