NCT05364255

A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]AZD9833

A Phase I, Open-Label, Single-Dose, Single-Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]AZD9833 After Oral Administration in Healthy Post-Menopausal Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• ER-positive, HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	[14C]AZD9833 Oral Solution, 75 mg	Oral Solution, 75 mg (NMT 0.67 MBq) - oral, fasted

Timeline

• Start date: 2022-05-10
• Primary completion: 2022-06-20
• Completion: 2022-06-20
• First posted: 2022-05-06
• Last updated: 2024-06-21

Locations

1 site across 1 country: United Kingdom