Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Radioactive tag reveals Drug's journey in healthy volunteers

NCT ID NCT07320521

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how the body absorbs, breaks down, and gets rid of a new breast cancer medicine called HRS-8080. Six healthy postmenopausal women took a single dose of the drug with a radioactive tag so researchers could track it. The goal was to understand the drug's path through the body and check its safety, not to treat any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

6 people

The number who actually took part.

Started

Jan 2026

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy postmenopausal female. 2. 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). 3. The subject must have regular bowel movements. Exclusion Criteria: 1. 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. 2. 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. 3. Having taken any clinical trial drug or participated in any drug clinical trial within the three months prior to the screening period. 4. Those who have received a vaccine within one month before screening or plan to receive a vaccine during the trial period. 5. 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. 6. 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. 7. 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. 8. 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. 9. 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. 10. 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. 11. 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. 12. 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. 13. 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. 14. Any significant abnormalities in the 12-lead electrocardiogram during screening were considered clinically significant by the researchers. 15. 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. 16. 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. 17. There was evidence of renal insufficiency during screening. 18. 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. 19. 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. 20. Any drugs that inhibit or induce the activity of liver drug-metabolizing enzymes or transporters have been used within 30 days prior to screening. 21. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.