A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in He… (NCT07537231) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Female Participants
China6 participantsStarted 2026-04-09
Plain-language summary
This is a single-center, non-randomized, open-label, single-dose clinical PK study in healthy postmenopausal female participants.
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy postmenopausal female participants meeting the menopause criteria at screening visit: natural menopause (defined as continuous spontaneous amenorrhea ≥ 12 months) or continuous spontaneous amenorrhea ≥ 6 months with serum follicle-stimulating hormone (FSH) \> 40 IU/L, or ≥ 6 weeks after bilateral oophorectomy for benign disease (with or without hysterectomy);
. Age at the time of signing the informed consent form (ICF): 40-65 years old (inclusive);
. Body mass index (BMI) range of 19-27.9 kg/m2 (inclusive), and body weight not less than 45 kg;
. Fully understand the purpose and requirements of this study, and voluntarily sign the ICF;
. Able to communicate well with the study personnel and to complete the study in accordance with the protocol.
Exclusion criteria
. Clinically significant abnormalities found during vital signs, physical examination, chest X-ray (posteroanterior view), ophthalmological examination, digital rectal examination, abdominal B-ultrasound, or gynecologic ultrasound;
. Abnormal laboratory tests at screening (hematology, blood chemistry, coagulation function, urinalysis, stool routine and occult blood, thyroid function, parathyroid function, sex hormones, see Appendix 2 for details) that are judged by the investigator to be clinically significant;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TRA recovery rate and cumulative TRA recovery rate for each time interval in excreta (urine and feces);
Timeframe: From the first administration until 240 hours later
2
Percentage of parent drug and its metabolites in human plasma relative to TRA exposure (%AUC);
Timeframe: From the first administration until 240 hours later
3
Percentage of parent drug and its metabolites in human urine and feces relative to the administered dose (%Dose); Identification of major metabolites in human plasma, urine, and feces;
Timeframe: From the first administration until 240 hours later
4
PK parameters of TRA in human plasma and whole blood: Cmax
Timeframe: From the first administration until 168 hours later
5
PK parameters of TRA in human plasma and whole blood: Tmax
Timeframe: From the first administration until 168 hours later
6
PK parameters of TRA in human plasma and whole blood: t1/2
Timeframe: From the first administration until 168 hours later
. Resting corrected QT interval (corrected using Fridericia's formula, QTcF = QT/RR\^1/3) obtained from 12-lead ECG \> 460 ms for females; or other abnormalities judged by the investigator to be clinically significant;
. Clinically significant abnormal results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody IgG (Anti-HCV IgG), treponema pallidum antibody, or human immunodeficiency virus antibody as judged by the investigator;
. Abnormal serum pregnancy test results judged clinically significant by the investigator; participants with natural menopause, total hysterectomy, or bilateral oophorectomy may be exempted from pregnancy testing;
. Use of any prescription drugs within 4 weeks prior to first dose \[including but not limited to any drugs that alter liver enzyme activity (e.g., glucocorticoids, sex hormones, anticonvulsants, cyclosporine, etc.)\], or use of any over-the-counter drugs (including but not limited to Chinese herbal medicines, Chinese herbal compound preparations, health products, etc.) and vitamin supplements within 2 weeks prior to first dose; including use of cytochrome P450 1A2 (CYP1A2) inducers within 3 months prior to administration of the investigational product, or use of CYP1A2 inhibitors within 2 weeks or 5 half-lives (whichever is longer) prior to administration (see Appendix 1 for details);
. History of syncope with hypotension, orthostatic hypotension, or hypertension within the past 2 years;
. History of any clinically significant disease, or any disease or condition that, in the opinion of the investigator, could affect the study results, including but not limited to circulatory, respiratory, endocrine, nervous, digestive, or urinary system, hematological, immunological, psychiatric, and metabolic diseases;
PK parameters of TRA in human plasma and whole blood: MRT
Timeframe: From the first administration until 168 hours later
8
PK parameters of TRA in human plasma and whole blood: AUC0-t
Timeframe: From the first administration until 168 hours later
9
PK parameters of TRA in human plasma and whole blood: AUC0-∞
Timeframe: From the first administration until 168 hours later
10
PK parameters of TRA in human plasma and whole blood:λz
Timeframe: From the first administration until 168 hours later
11
PK parameters of TRA in human plasma and whole blood: CL/F
Timeframe: From the first administration until 168 hours later
12
PK parameters of TRA in human plasma and whole blood: Vz/F
Timeframe: From the first administration until 168 hours later