A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]AZD9833
Condition: ER-positive, HER2-negative Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The Sponsor is developing the test medicine, AZD9833 for the potential treatment of estrogen
      receptor (ER)-positive breast cancer.

      This single-part, healthy volunteer study will try to identify how the test medicine is taken
      up, broken down and removed from the body. To help investigate this, the test medicine is
      radiolabelled, which means that the test medicine has a radioactive component (carbon-14)
      which helps us to track where the test medicine is in the body. The safety and tolerability
      of the test medicine will also be studied.

      This study will take place at one non-NHS site, and will consist of a single study period
      involving up to 6 post-menopausal female volunteers, aged between 50 to 70 years.
    

Detailed description: 
      The Sponsor is developing the test medicine, AZD9833 for the potential treatment of estrogen
      receptor (ER)-positive breast cancer.

      Breast cancer is the second most common type of cancer in the UK and worldwide. Most women
      diagnosed with breast cancer are over the age of 50, but younger women and men can also get
      breast cancer. AZD9833 has the potential to prevent ER activity and increase overall survival
      in advanced breast cancer patients.

      This single-part, healthy volunteer study will try to identify how the test medicine is taken
      up, broken down and removed from the body. To help investigate this, the test medicine is
      radiolabelled, which means that the test medicine has a radioactive component (carbon-14)
      which helps us to track where the test medicine is in the body. The safety and tolerability
      of the test medicine will also be studied.

      This study will take place at one non-NHS site, and will consist of a single study period
      involving up to 6 post-menopausal female volunteers, aged between 50 to 70 years.

      On Day 1, volunteers will receive a 75 mg dose of [14C]AZD9833 oral solution in the fasted
      state (on an empty stomach).

      Volunteer's blood, urine and faeces will be taken throughout the study for analysis of the
      test medicine and it's breakdown products (metabolites) and for volunteer safety.

      Volunteers will remain in the clinical unit until Day 8, however if the relevant
      radioactivity criteria have not been met, volunteers may be required to remain at the clinic
      until Day 10. If relevant criteria have not been met at this point, home collections of urine
      and/or faeces may be required.

      Volunteers are expected to be involved in this study for approximately 6 weeks from screening
      to discharge.
    

Intervention name(s): [14C]AZD9833 Oral Solution, 75 mg
Intervention type(s): Drug
Intervention description(s): Oral Solution, 75 mg (NMT 0.67 MBq) - oral, fasted
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer