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

Study identifier:D8532C00005

ClinicalTrials.gov identifier:NCT05364255

EudraCT identifier:2022-000834-40

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

ER-positive, HER2-negative breast cancer

Phase

Phase 1

Healthy volunteers

Yes

Study drug

[14C]AZD9833 Oral Solution, 75 mg

Sex

Female

Actual Enrollment

6

Study type

Interventional

Age

50 Years - 70 Years

Date

Study Start Date: 10 May 2022
Primary Completion Date: 20 Jun 2022
Study Completion Date: 20 Jun 2022

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Quotient Sciences Ltd

Inclusion and exclusion criteria