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Breast CancerPhase 1NCT07320521

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

A Phase 1 study testing [14C]HRS-8080 in people with Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
[14C]HRS-8080
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
9 Jan 2026to 28 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Having taken any clinical trial drug or participated in any drug clinical trial within the three months prior to the screening period.
  • Those who have received a vaccine within one month before screening or plan to receive a vaccine during the trial period.
  • People with allergic constitutions, such as those with a known history of allergy to two or more substances; Or those who, as determined by the researchers, may be allergic to the investigational drug or its excipients.
  • Those with a history of fainting at the sight of needles or blood may have difficulty in blood collection or cannot tolerate venipuncture for blood collection.
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  • Workers engaged in work that requires long-term exposure to radioactive conditions; Or those who have had significant radioactive exposure within one year prior to the test or have participated in radioactive drug labeling tests.
  • Those who show abnormal results through comprehensive physical examination, vital signs, laboratory tests, 12-lead electrocardiogram, chest X-ray, digital rectal examination, and abdominal B-ultrasound, and are determined by the researcher to have clinical significance.
  • Sex hormones: Those with abnormal tests for luteinizing hormone (LH), progesterone (P), testosterone (T), and prolactin (PRL), and who are determined by the researcher to have clinical significance.
  • Excessive drinking or frequent alcohol consumption within the six months prior to the screening period, that is, consuming more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); Or the result of the alcohol breath test during the screening period is ≥20 mg/dl; Or those who are unable to quit alcohol during the trial period.
  • Those who smoked more than five cigarettes per day or habitually used nicotine-containing products in the three months prior to the screening period; Or those who are unable to withdraw during the trial period.
  • Abuse of drugs or use of soft drugs (such as marijuana) in the three months prior to the screening period or use of hard drugs (such as cocaine, amphetamines, etc.) in the year prior to the screening period; Or positive urine drug abuse (drug) test during the screening period.
  • Those who habitually consume grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages and are unable to quit during the trial period.
  • Any significant abnormalities in the 12-lead electrocardiogram during screening were considered clinically significant by the researchers.
  • Those with any history of serious clinical diseases or diseases or conditions that the researcher believes may affect the trial results, such as a history of gastrointestinal, liver or kidney diseases or current existence of such diseases, or any diseases known to interfere with drug absorption, distribution, metabolism or excretion.
  • Those who test positive for any one of hepatitis B surface antigen or hepatitis B e antigen, hepatitis C virus antibody, Treponema pallidum antibody, or the combined test of human immunodeficiency virus antigen/antibody.
  • There was evidence of renal insufficiency during screening.
  • Those who have undergone major surgery within 6 months prior to the screening period or whose surgical incisions have not fully healed; Major surgeries include but are not limited to those with significant bleeding risks, prolonged general anesthesia periods, or incision biopsies or obvious traumatic injuries.
  • Hemorrhoids or perianal diseases accompanied by regular or ongoing bleeding during defecation; Subjects who are unable to swallow, or have a history of gastrointestinal dysfunction such as irritable bowel syndrome, inflammatory bowel disease, or have undergone surgeries like gastrectomy, which the researchers determine may affect drug absorption, as well as those with habitual constipation or diarrhea.
  • Any drugs that inhibit or induce the activity of liver drug-metabolizing enzymes or transporters have been used within 30 days prior to screening.
  • In the 14 days prior to screening or currently using any prescription drugs, over-the-counter drugs, vitamin products, health supplements or Chinese herbal medicines, etc., unless it has been evaluated that the use of such drugs will not interfere with the research objectives and will not endanger the safety of the subjects.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: A Phase I Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subjects.

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.

Conditions
Breast Cancer
Being tested
[14C]HRS-8080
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]HRS-8080Drug

    Subjects will receive single dose of orally [14C]HRS-8080.

Study groups in NCT07320521
Study groupRoleWhat they receive
[14C]HRS-8080 GroupExperimentalNot described
Receives: Drug: [14C]HRS-8080

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The cumulative amount of HRS-8080 excreted.

    Measured: 0 hour to 360 hours.

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

    Measured: 0 hour to 360 hours.

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

    Measured: 0 hour to 360 hours.

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

    Measured: 0 hour to 360 hours.

  5. Maximum concentration (Cmax).

    Pharmacokinetic parameters for total radioactivity in plasma.

    Measured: 0 hour to 336 hours.

  6. Time of maximum concentration (Tmax).

    Pharmacokinetic parameters for total radioactivity in plasma.

    Measured: 0 hour to 336 hours.

  7. Area under the concentration-time curve (AUC).

    Pharmacokinetic parameters for total radioactivity in plasma.

    Measured: 0 hour to 336 hours.

  8. Elimination half-life (t1/2).

    Pharmacokinetic parameters for total radioactivity in plasma.

    Measured: 0 hour to 336 hours.

  9. Apparent clearance (CL/F).

    Pharmacokinetic parameters for total radioactivity in plasma.

    Measured: 0 hour to 336 hours.

  10. Apparent volume of distribution (Vz/F).

    Pharmacokinetic parameters for total radioactivity in plasma.

    Measured: 0 hour to 336 hours.

  11. Ratio of total radioactivity in whole blood to plasma.

    Measured: 0 hour to 360 hours.

Secondary outcomes (7)

  1. Maximum concentration (Cmax).

    Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.

    Measured: 0 hour to 336 hours.

  2. Time of maximum concentration (Tmax).

    Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.

    Measured: 0 hour to 336 hours.

  3. Area under the concentration-time curve (AUC).

    Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.

    Measured: 0 hour to 336 hours.

  4. Elimination half-life (t1/2).

    Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.

    Measured: 0 hour to 336 hours.

  5. Apparent clearance (CL/F).

    Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.

    Measured: 0 hour to 336 hours.

  6. Apparent volume of distribution (Vz/F).

    Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.

    Measured: 0 hour to 336 hours.

  7. Adverse events (AEs).

    Measured: Day -7 to Day 23.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start9 Jan 2026
  3. Primary completion28 Jan 2026
  4. Study completion28 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07320521
Sponsor's protocol ID
HRS-8080-103
Status last verified
Jun 2026
First submitted
22 Dec 2025
Last updated
8 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]HRS-8080 in people with Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The cumulative amount of HRS-8080 excreted. (time frame: 0 hour to 360 hours.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07320521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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