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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: [14C]HRS-8080

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yifan Li; Phone Number: +86-0518-82342973; Email: yifan.li@hengrui.com
• Study Contact Backup: Name: Peng Chen; Phone Number: +86-0518-82342973; Email: peng.chen.pc3@hengrui.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • The First Affiliated Hospital of Soochow University
      • Principal Investigator: Liyan Miao
      • Contact: Liyan Miao; Phone Number: +86-0512-67972858; Email: miaolysuzhou@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]HRS-8080 Group	Drug: [14C]HRS-8080; Subjects will receive single dose of orally [14C]HRS-8080.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cumulative amount of HRS-8080 excreted.		0 hour to 360 hours.
Percentage of parent drug and its metabolite(s) relative to total radioactive exposure in plasma.		0 hour to 360 hours.
Percentage of administered dose excreted as parent drug and its metabolite(s) in urine.		0 hour to 360 hours.
Percentage of administered dose excreted as parent drug and its metabolite(s) in feces.		0 hour to 360 hours.
Maximum concentration (Cmax).	Pharmacokinetic parameters for total radioactivity in plasma.	0 hour to 336 hours.
Time of maximum concentration (Tmax).	Pharmacokinetic parameters for total radioactivity in plasma.	0 hour to 336 hours.
Area under the concentration-time curve (AUC).	Pharmacokinetic parameters for total radioactivity in plasma.	0 hour to 336 hours.
Elimination half-life (t1/2).	Pharmacokinetic parameters for total radioactivity in plasma.	0 hour to 336 hours.
Apparent clearance (CL/F).	Pharmacokinetic parameters for total radioactivity in plasma.	0 hour to 336 hours.
Apparent volume of distribution (Vz/F).	Pharmacokinetic parameters for total radioactivity in plasma.	0 hour to 336 hours.
Ratio of total radioactivity in whole blood to plasma.		0 hour to 360 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration (Cmax).	Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.	0 hour to 336 hours.
Time of maximum concentration (Tmax).	Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.	0 hour to 336 hours.
Area under the concentration-time curve (AUC).	Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.	0 hour to 336 hours.
Elimination half-life (t1/2).	Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.	0 hour to 336 hours.
Apparent clearance (CL/F).	Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.	0 hour to 336 hours.
Apparent volume of distribution (Vz/F).	Pharmacokinetic parameters for HRS-8080 and its metabolite(s) in plasma.	0 hour to 336 hours.
Adverse events (AEs).		Day -7 to Day 23.

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: HRS-8080-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No