A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Female Participants

NCT07537231 | Not Yet Recruiting Phase 1

• 1 other identifier: GenSci074-104
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, non-randomized, open-label, single-dose clinical PK study in healthy postmenopausal female participants.

Conditions

Healthy Postmenopausal Women; Absorption; Metabolism; Excretion

Outcome Measures

Primary Outcomes (12)

• TRA recovery rate and cumulative TRA recovery rate for each time interval in excreta (urine and feces);

  From the first administration until 240 hours later

• Percentage of parent drug and its metabolites in human plasma relative to TRA exposure (%AUC);

  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;

  From the first administration until 240 hours later

• PK parameters of TRA in human plasma and whole blood: Cmax

  From the first administration until 168 hours later

• PK parameters of TRA in human plasma and whole blood: Tmax

  From the first administration until 168 hours later

• PK parameters of TRA in human plasma and whole blood: t1/2

  From the first administration until 168 hours later

• PK parameters of TRA in human plasma and whole blood: MRT

  From the first administration until 168 hours later

• PK parameters of TRA in human plasma and whole blood: AUC0-t

  From the first administration until 168 hours later

• PK parameters of TRA in human plasma and whole blood: AUC0-∞

  From the first administration until 168 hours later

• PK parameters of TRA in human plasma and whole blood:λz

  From the first administration until 168 hours later

• PK parameters of TRA in human plasma and whole blood: CL/F

  From the first administration until 168 hours later

• PK parameters of TRA in human plasma and whole blood: Vz/F

  From the first administration until 168 hours later

Study Arms (1)

healthy postmenopausal female participants

EXPERIMENTAL

Drug: [14C]GS1-144

Interventions

[14C]GS1-144 DRUG

30 mg/100 µCi \[14C\]GS1-144, taken orally once

healthy postmenopausal female participants

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Suzhou, 214062, China

Location

Central Study Contacts

Zhao Yiqing

CONTACT

+86 13358100007; 13358100007@126.com

Study Design

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

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion: April 18, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-03

Locations

CN (1)