NCT05419401

A Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib)

A Phase I Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Capivasertib film-coated tablet, 200 mg	400mg dose, oral, fasted
DRUG	[14C]AZD5363 (Capivasertib)	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

Timeline

• Start date: 2022-04-11
• Primary completion: 2022-07-12
• Completion: 2022-07-12
• First posted: 2022-06-15
• Last updated: 2022-07-22

Locations

1 site across 1 country: United Kingdom