A Study to Assess the Mass Balance of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subj… (NCT07320521) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Assess the Mass Balance of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subjects.
China6 participantsStarted 2026-01
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 range18 Years – 70 Years
SexFEMALE
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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.
✕. 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.
What they're measuring
1
The cumulative amount of HRS-8080 excreted.
Timeframe: 0 hour to 360 hours.
2
Percentage of parent drug and its metabolite(s) relative to total radioactive exposure in plasma.
Timeframe: 0 hour to 360 hours.
3
Percentage of administered dose excreted as parent drug and its metabolite(s) in urine.
Timeframe: 0 hour to 360 hours.
4
Percentage of administered dose excreted as parent drug and its metabolite(s) in feces.
. 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.
9
Apparent clearance (CL/F).
Timeframe: 0 hour to 336 hours.
10
Apparent volume of distribution (Vz/F).
Timeframe: 0 hour to 336 hours.
11
Ratio of total radioactivity in whole blood to plasma.