A Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib)
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The Sponsor is developing the test medicine, Capivasertib, for the potential treatment of
      primary breast and prostate cancer. This two-part healthy volunteer study will try to
      identify the absolute bioavailability (amount of the test medicine that enters the blood
      stream), mass balance recovery (how much radioactivity can be recovered from the urine and
      faeces) and the rates and routes of elimination of the test medicine.
    

Detailed description: 
      The Sponsor is developing the test medicine, Capivasertib, for the potential treatment of
      primary breast and prostate cancer. Cancer is a condition where cells in a specific part of
      the body grow and reproduce uncontrollably, causing a growth called a tumour. The cancerous
      cells can invade and destroy surrounding healthy tissue, including organs. The four most
      common types of cancer within the UK are: breast, lung, prostate and bowel cancer. This
      two-part healthy volunteer study will try to identify the absolute bioavailability (amount of
      the test medicine that enters the blood stream), mass balance recovery (how much
      radioactivity can be recovered from the urine and faeces) and the rates and routes of
      elimination of the test medicine. Two out of three recipes of the test medicine are
      radiolabelled with carbon-14. 'Radiolabelled' means that the test medicine has a radioactive
      component (carbon-14) which helps us to track where the test medicine is in the body. This
      study will consist of two periods involving up to eight healthy male volunteers aged 30-65
      and will take place at one non-NHS site. In Part 1, volunteers will receive a single dose of
      2 non-radiolabelled oral tablets in the fasted state followed by an intravenous infusion
      (solution into the vein) of radiolabelled test medicine 1 hour 15 mins minutes later.
      Volunteers will be discharged from the clinical unit on Day 5. In Part 2, volunteers will
      receive a single oral dose of a radiolabelled oral solution in the fasted state. Volunteers
      will be discharged on Day 8, however may be required to remain at the clinical unit until Day
      10 if the mass balance criteria have not been met by Day 8. Volunteers will receive a follow
      up phone call between Day 15 and Day 19. Volunteer's blood, urine and faeces will be taken
      throughout the study for analysis of the test medicine, radiation and for safety. Volunteers
      are expected to be involved in this study for approximately 9 weeks from screening to the
      follow-up call.
    

Intervention name(s): Capivasertib film-coated tablet, 200 mg; [14C]AZD5363 (Capivasertib)
Intervention type(s): Drug; Drug
Intervention description(s): 400mg dose, oral, fasted; Solution for Infusion 20 µg/mL (NMT 37.0 kBq/5 mL) - 100 µg; 5 mL, Intravenous
Oral Solution, 400 mg (NMT 4.8 MBq) - 400mg; 100mL, oral, fasted
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteer