CompletedPhase 1

A Study to Assess the Mass Balance of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subjects.

China6 participantsStarted 2026-01-09

Plain-language summary

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.

Who can participate

Age range

18 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.

Inclusion criteria

. Healthy postmenopausal female.
. Body weight must be ≥45 kg at screening, and Body Mass Index (BMI) must be within the range of 19 kg/m² to 26 kg/m² (inclusive).
. The subject must have regular bowel movements.

Exclusion criteria

. Any clinically significant disease or disorder that the researcher believes may pose a risk to the researcher due to participation in the study, or may affect the research results.
. Have participated in blood donation within 3 months prior to screening, with a blood donation volume of ≥400 mL or a blood loss of ≥400 mL; Have participated in blood donation within one month and donated at least 200 mL of blood or lost at least 200 mL of blood; Those who receive blood transfusion within one month or plan to donate blood within three months after the end of this trial.

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 HRS-8080 excreted.

Timeframe: 0 hour to 360 hours.

Percentage of parent drug and its metabolite(s) relative to total radioactive exposure in plasma.

Timeframe: 0 hour to 360 hours.

Percentage of administered dose excreted as parent drug and its metabolite(s) in urine.

Timeframe: 0 hour to 360 hours.

Percentage of administered dose excreted as parent drug and its metabolite(s) in feces.

Timeframe: 0 hour to 360 hours.

Maximum concentration (Cmax).

Timeframe: 0 hour to 336 hours.

Time of maximum concentration (Tmax).

Timeframe: 0 hour to 336 hours.

Area under the concentration-time curve (AUC).

Timeframe: 0 hour to 336 hours.

Trial details

NCT IDNCT07320521

SponsorShandong Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-28

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range

18 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.

Inclusion criteria

. Healthy postmenopausal female.
. Body weight must be ≥45 kg at screening, and Body Mass Index (BMI) must be within the range of 19 kg/m² to 26 kg/m² (inclusive).
. The subject must have regular bowel movements.

Exclusion criteria

. Any clinically significant disease or disorder that the researcher believes may pose a risk to the researcher due to participation in the study, or may affect the research results.
. Have participated in blood donation within 3 months prior to screening, with a blood donation volume of ≥400 mL or a blood loss of ≥400 mL; Have participated in blood donation within one month and donated at least 200 mL of blood or lost at least 200 mL of blood; Those who receive blood transfusion within one month or plan to donate blood within three months after the end of this trial.

What they're measuring

The cumulative amount of HRS-8080 excreted.

Timeframe: 0 hour to 360 hours.

Percentage of parent drug and its metabolite(s) relative to total radioactive exposure in plasma.

Timeframe: 0 hour to 360 hours.

Percentage of administered dose excreted as parent drug and its metabolite(s) in urine.

Timeframe: 0 hour to 360 hours.

Percentage of administered dose excreted as parent drug and its metabolite(s) in feces.

Timeframe: 0 hour to 360 hours.

Maximum concentration (Cmax).

Timeframe: 0 hour to 336 hours.

Time of maximum concentration (Tmax).

Timeframe: 0 hour to 336 hours.

Area under the concentration-time curve (AUC).

Timeframe: 0 hour to 336 hours.