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

NCT07320521 | Not Yet Recruiting Phase 1

• 1 other identifier: HRS-8080-103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (7)

• Maximum concentration (Cmax).

  0 hour to 336 hours.

• Time of maximum concentration (Tmax).

  0 hour to 336 hours.

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

  0 hour to 336 hours.

• Elimination half-life (t1/2).

  0 hour to 336 hours.

• Apparent clearance (CL/F).

  0 hour to 336 hours.

Study Arms (1)

[14C]HRS-8080 Group

EXPERIMENTAL

Drug: [14C]HRS-8080

Interventions

[14C]HRS-8080 DRUG

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

[14C]HRS-8080 Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Peng Chen

CONTACT

+86-0518-82342973; peng.chen.pc3@hengrui.com

Yifan Li

CONTACT

+86-0518-82342973; yifan.li@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

CN (1)