Healthy Postmenopausal WomenPhase 1NCT07537231
A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Female Participants
A Phase 1 study testing [14C]GS1-144 in people with Healthy Postmenopausal Women and Absorption, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, non-randomized, open-label, single-dose clinical PK study in healthy postmenopausal female participants. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Postmenopausal Women, Absorption, Metabolism
- What is being tested?
- [14C]GS1-144
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Auxiliary Examinations:
- 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;
- 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;
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- Medication History:
- 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);
- Medical and Surgical History:
- 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;
- History of organic heart disease, cardiac failure, myocardial infarction, angina pectoris, unexplained arrhythmia, Torsades de Pointes, ventricular tachycardia, atrioventricular block, long QT syndrome, or symptoms and family history of long QT syndrome (indicated by genetic proof or sudden cardiac death of a close relative at a young age);
- History of dysphagia, oesophageal stenosis, or gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhoea, or malabsorption syndrome, or a history of severe vomiting or diarrhoea within one week prior to screening;
- History of surgery that, in the investigator's judgment, would affect drug absorption, distribution, metabolism, or excretion (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy), or have undergone major surgery within 6 months prior to screening or whose surgical incision has not fully healed; major surgery includes, but is not limited to, any surgery with a significant risk of haemorrhage, a prolonged period of general anaesthesia, or incisional biopsy or significant traumatic injury, or planning to undergo surgery during the study;
- History of any known allergy to drugs, food, or environmental factors, especially allergy to components similar to the investigational product, or having an allergic constitution;
- Have symptomatic haemorrhoids or perianal diseases accompanied by regular/active haematochezia, irritable bowel syndrome, or inflammatory bowel disease;
- History of abnormal urination due to congenital or acquired urinary tract stenosis caused by infection/tumor, or bladder dysfunction;
- Clinically significant major infection within 2 months prior to screening (e.g., requiring hospitalization or parenteral antibacterial therapy), or active systemic bacterial, viral, or fungal infection, or clinically significant pyrexia, or unresolved infection within 2 weeks prior to screening, or a history of herpes zoster within 3 months prior to screening;
- Known or suspected history of immunodeficiency (e.g., history of frequent recurrent infections), history of hereditary or acquired complement deficiency;
- Lifestyle Habits:
- Habitual diarrhoea or average bowel movement frequency of less than once per day;
- Alcohol breath test result > 0 mg/100 mL or alcohol abuse within 3 months prior to screening, i.e., weekly alcohol consumption exceeding 14 units (1 standard unit equals 17.5 mL or 14 g pure alcohol; alcohol content for different types of alcoholic beverages is indicated by volume percentage; 1 standard unit is approximately equivalent to 35 mL of 50° liquor or 350 mL of 5° beer), or unwillingness to stop consuming alcohol or any alcohol-containing products during the study period;
- Use of tobacco products, nicotine, or nicotine-containing products (e.g., e-cigarettes) within 1 month prior to screening, or unwillingness to stop smoking during the study period;
- History of drug abuse or drug addiction, or a positive urine drug abuse screen;
- Excessive consumption (more than 8 cups per day, 1 cup = 250 mL) of tea, coffee, or caffeinated beverages daily within 3 months prior to screening; or intake of any foods or beverages containing or metabolized to produce caffeine or xanthine (e.g., coffee, tea, chocolate, cola, etc.) within 24 hours prior to admission;
- Have special dietary requirements or are unable to comply with the standardized diet (e.g., intolerance to standard meals); or refusal to abstain from foods or beverages that may affect the metabolism of the investigational product (e.g., foods or beverages containing grapefruit, carambola, or their products, etc.) from 48 hours before dosing until the end of the study;
- Plan to engage in strenuous exercise during the study;
- Others:
- Occupation involving long-term exposure to radioactive conditions; or significant radioactive exposure (e.g., ≥2 chest/abdominal CT scans, or ≥3 other types of X-ray examinations) within 1 year prior to screening, or participation in a radiolabeled drug trial within 1 year prior to screening;
- Have had blood loss or blood donation of >400 mL within 3 months prior to screening, or have had blood loss or blood donation of >200 mL within 1 month prior to dosing, or have received a transfusion of blood or blood components within 1 month, or plan to donate blood during the study drug administration period or within 3 months after discontinuation of the study drug;
- History of needle phobia or hemophobia, or difficulty with blood collection or inability to tolerate venipuncture blood collection;
- Have participated in any clinical trial and received an investigational drug or used an investigational device within 3 months prior to screening; or plan to participate in other clinical trials during this study, or not attending the clinical trial in person;
- Have received any vaccination within 4 weeks prior to screening or plan to receive any vaccination during the study or within 1 month after the end of the study;
- Have other factors deemed by the investigator to make the participant unsuitable for participation in this study, or participants who withdraw from the study for personal reasons.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center, non-randomized, open-label, single-dose clinical PK study in healthy postmenopausal female participants.
Read the detailed description
This is a single-center, single-dose, open-label design study, planned to enroll 6-8 healthy postmenopausal female participants to evaluate the human mass balance of [14C]GS1-144. Each participant will receive a single oral dose of approximately 30 mg/100 µCi of [14C]GS1-144 oral formulation. During the study, blood, urine, and feces samples will be collected at specified time points/intervals. By measuring the the total radioactivity （TRA ）concentration in whole blood and plasma, and the concentrations of GS1-144, its metabolite M1, and other metabolites (if applicable) in plasma, the PK parameters of TRA of [14C]GS1-144 in plasma and whole blood (if applicable) and the PK parameters of GS1-144, its metabolite M1, and other metabolites (if applicable) in plasma will be calculated, and the distribution of TRA between whole blood and plasma will be determined; by measuring the amount of radioactivity in urine and feces, the TRA recovery, radioactivity excretion data, and main excretion pathways will be obtained; through the analysis of the radioactive metabolite profile in plasma, urine, and feces and the structural identification of major metabolites, the metabolic and elimination pathways of GS1-144 in humans will be determined.
- Conditions
- Healthy Postmenopausal Women, Absorption, Metabolism, Excretion
- Being tested
- [14C]GS1-144
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]GS1-144Drug
30 mg/100 µCi [14C]GS1-144, taken orally once
| Study group | Role | What they receive |
|---|---|---|
| healthy postmenopausal female participants | Experimental | Not described Receives: Drug: [14C]GS1-144 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRA recovery rate and cumulative TRA recovery rate for each time interval in excreta (urine and feces);
Measured: From the first administration until 240 hours later
Percentage of parent drug and its metabolites in human plasma relative to TRA exposure (%AUC);
Measured: From the first administration until 240 hours later
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;
Measured: From the first administration until 240 hours later
PK parameters of TRA in human plasma and whole blood: Cmax
Measured: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: Tmax
Measured: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: t1/2
Measured: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: MRT
Measured: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: AUC0-t
Measured: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: AUC0-∞
Measured: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood:λz
Measured: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: CL/F
Measured: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: Vz/F
Measured: From the first administration until 168 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start9 Apr 2026
- Primary completion18 Apr 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Postmenopausal WomenStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537231
- Sponsor's protocol ID
- GenSci074-104
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Female Participants
- ClinicalTrials.gov ID
- NCT07537231
- Acronym / sponsor ID
- GenSci074-104
- Conditions
- Healthy Postmenopausal Women, Absorption, Metabolism, Excretion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 18 Apr 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, non-randomized, open-label, single-dose clinical PK study in healthy postmenopausal female participants.
Detailed description
This is a single-center, single-dose, open-label design study, planned to enroll 6-8 healthy postmenopausal female participants to evaluate the human mass balance of [14C]GS1-144. Each participant will receive a single oral dose of approximately 30 mg/100 µCi of [14C]GS1-144 oral formulation. During the study, blood, urine, and feces samples will be collected at specified time points/intervals. By measuring the the total radioactivity （TRA ）concentration in whole blood and plasma, and the concentrations of GS1-144, its metabolite M1, and other metabolites (if applicable) in plasma, the PK parameters of TRA of [14C]GS1-144 in plasma and whole blood (if applicable) and the PK parameters of GS1-144, its metabolite M1, and other metabolites (if applicable) in plasma will be calculated, and the distribution of TRA between whole blood and plasma will be determined; by measuring the amount of radioactivity in urine and feces, the TRA recovery, radioactivity excretion data, and main excretion pathways will be obtained; through the analysis of the radioactive metabolite profile in plasma, urine, and feces and the structural identification of major metabolites, the metabolic and elimination pathways of GS1-144 in humans will be determined.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy postmenopausal female participants | Experimental | Drug: [14C]GS1-144 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (34 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]GS1-14430 mg/100 µCi [14C]GS1-144, taken orally once | Drug | healthy postmenopausal female participants |
Primary outcome
TRA recovery rate and cumulative TRA recovery rate for each time interval in excreta (urine and feces);
Time frame: From the first administration until 240 hours later
Percentage of parent drug and its metabolites in human plasma relative to TRA exposure (%AUC);
Time frame: From the first administration until 240 hours later
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;
Time frame: From the first administration until 240 hours later
PK parameters of TRA in human plasma and whole blood: Cmax
Time frame: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: Tmax
Time frame: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: t1/2
Time frame: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: MRT
Time frame: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: AUC0-t
Time frame: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: AUC0-∞
Time frame: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood:λz
Time frame: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: CL/F
Time frame: From the first administration until 168 hours later
PK parameters of TRA in human plasma and whole blood: Vz/F
Time frame: From the first administration until 168 hours later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]GS1-144 in people with Healthy Postmenopausal Women and Absorption, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRA recovery rate and cumulative TRA recovery rate for each time interval in excreta (urine and feces); (time frame: From the first administration until 240 hours later). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.