A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in He⦠(NCT07537231) | Clinical Trial Compass
Active β 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 range40 Years β 65 Years
SexFEMALE
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Inclusion criteria
β. Healthy postmenopausal female participants meeting the menopause criteria at screening visit: natural menopause (defined as continuous spontaneous amenorrhea β₯ 12 months) or continuous spontaneous amenorrhea β₯ 6 months with serum follicle-stimulating hormone (FSH) \> 40 IU/L, or β₯ 6 weeks after bilateral oophorectomy for benign disease (with or without hysterectomy);
β. Age at the time of signing the informed consent form (ICF): 40-65 years old (inclusive);
β. Body mass index (BMI) range of 19-27.9 kg/m2 (inclusive), and body weight not less than 45 kg;
β. Fully understand the purpose and requirements of this study, and voluntarily sign the ICF;
β. Able to communicate well with the study personnel and to complete the study in accordance with the protocol.
Exclusion criteria
β. 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;
β. 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;
β. 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;
β
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
7
PK parameters of TRA in human plasma and whole blood: MRT
Timeframe: From the first administration until 168 hours later
. 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;
β. 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;
β. 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);
β. History of syncope with hypotension, orthostatic hypotension, or hypertension within the past 2 years;
β. 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;
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-β
Timeframe: From the first administration until 168 hours later
10
PK parameters of TRA in human plasma and whole blood:Ξ»z
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