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

AstraZeneca (Sweden)0 sites6 target enrollmentMay 5, 2022

ConditionsER-positive, HER2-negative breast cancer Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ER-positive, HER2-negative breast cancer
Sponsor: AstraZeneca (Sweden)
Enrollment: 6
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 5, 2022

End Date

June 20, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

AstraZeneca (Sweden)

Eligibility Criteria

Inclusion Criteria

•1\. Provision of signed and dated, written informed consent prior to any study\-specific procedures
•2\. Aged between 50 to 70 years inclusive at the time of signing informed consent
•3\. Healthy post\-menopausal females, defined as post\-menopausal by fulfilling the following criterion:
•3\.1\. Amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and without an alternative medical or surgical cause and confirmed by an FSH result of \=30 IU/l
•4\. Must be willing and able to communicate and participate in the whole study
•5\. Have a body mass index (BMI) between 19\.0 to 35\.0 kg/m², weigh at least 50 kg and no more than 100 kg inclusive as measured at screening.
•6\. Must have regular bowel movements (i.e. average stool production of \=1 and \=3 stools per day)

Exclusion Criteria

•1\. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer’s ability to participate in the study
•2\. History or presence of GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
•3\. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP
•4\. History of or ongoing clinically significant visual disturbances including but not limited to visual hallucinations, migraine with visual symptoms, blurred vision, frequent floaters/flashes associated with other symptoms such as dizziness
•5\. Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, at screening as judged by the Investigator.
•6\. Any clinically significant abnormal findings in vital signs at screening as judged by the Investigator, including systolic BP \<100 mmHg, diastolic BP \<50 mmHg or heart rate \<50 bpm. Vital signs outside these limits can be repeated once for confirmation
•7\. Any clinically significant abnormalities on 12\-lead ECG at screening, as judged by the Investigator, including non\-sinus rhythms, PR interval \<120 msec or \>220 msec, ventricular rate \<50 bpm or \>100 bpm, QRS interval \>120 msec, or QTcF \>470 msec as a mean of triplicate. ECGs can be repeated once in triplicate if parameters are outside these limits for confirmation
•8\. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of \<60 ml/min/1\.73m² using the Cockcroft\-Gault equation
•9\. Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), and human immunodeficiency virus (HIV) 1 and 2 antibodies
•10\. Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 4 weeks prior to Day 1, or less than 5 elimination half\-lives \+ 6 days prior to Day 1, whichever is longer. Note: subjects consented and screened, but not administered IMP in this study or a previous Phase I study, are not excluded