CompletedPhase 1

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

United Kingdom6 participantsStarted 2022-05-10

Plain-language 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.

Who can participate

Age range

50 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. any prescribed or over-the-counter drug (other than up to 4 g of paracetamol per day ) or herbal remedies in the 14 days before IMP administration or longer if the medication has a long half-life. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply, as determined by the Investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study
. atropine or atropine containing drugs, in the 14 days before IMP administration
. Systemic oestrogen-containing hormone replacement therapy in the 6 months prior to IMP administration

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The cumulative amount of AZD9833 excreted (CumAe)

Timeframe: Urine and faecal samples collected from pre-dose until 168 hours post-dose

The cumulative amount of AZD9833 excreted, expressed as a percentage of the radioactive dose administered (Cum%Ae)

Timeframe: Urine and faecal samples collected from pre-dose until 168 hours post-dose

Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry

Timeframe: Plasma samples collected from pre-dose until 168 hours post-dose

Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry

Timeframe: Urine samples collected from pre-dose until 168 hours post-dose

Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry

Timeframe: Faeces samples collected from pre-dose until 168 hours post-dose

Trial details

NCT IDNCT05364255

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-20

View on ClinicalTrials.gov More ER-positive, HER2-negative Breast Cancer trials