To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets . (NCT07534176) | Clinical Trial Compass
Not Yet RecruitingPhase 1
To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets .
China24 participantsStarted 2026-05-27
Plain-language summary
A Drug-Drug Interaction Study to Evaluate the Effect of Smoking (CYP1A2 Inducer) on the Pharmacokinetics Following a Single Oral Dose of GS1-144 Tablets in Chinese Healthy Postmenopausal Female Trial Participants
Who can participate
Age range40 Years β 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
β. Consecutive spontaneous amenorrhea β₯ 6 months but \< 12 months, with serum follicle-stimulating hormone (FSH) levels \> 40 IU/L.
β. β₯ 6 weeks after bilateral oophorectomy.
β. History of hysterectomy with preservation of one or both ovaries and FSH levels \> 40 IU/L.
Exclusion criteria
β. Known history of hypersensitivity to the investigational drug, any of its excipients, or related formulations; or a history of allergic disorders (including but not limited to asthma, urticaria); or being allergy-prone (e.g., known allergy to two or more substances).
β. History or current diagnosis of diseases of the circulatory, digestive, urinary, respiratory, endocrine and metabolic, hematological and lymphatic, immune, psychiatric and neurological, or dermatological systems, and deemed unsuitable for participation by the investigator.
β. History of severe infection, serious trauma, or major surgery within 6 months prior to screening, or planning to undergo surgery during the trial.
β. Blood donation or blood loss β₯ 400 mL, or receipt of blood transfusion within 3 months prior to screening, or planning to donate blood within 1 month after the end of the trial.
β. Use of any prescription medications \[including but not limited to drugs known to alter hepatic enzyme activity (e.g., glucocorticoids, sex hormones, anticonvulsants, cyclosporine)\] within 4 weeks prior to screening, or use of any over-the-counter (OTC) medications (including but not limited to herbal medicines, herbal compound prescriptions, health supplements) or vitamin supplements within 2 weeks prior to screening.
What they're measuring
1
Primary PK parameters for GS1-144: Cmax.
Timeframe: up to 72 hours
2
Primary PK parameters for GS1-144: AUC0-t.
Timeframe: up to 72 hours
3
Primary PK parameters for GS1-144: AUC0-β.
Timeframe: up to 72 hours
4
Secondary PK parameters of GS1-144: Tmax.
Timeframe: up to 72 hours
5
Secondary PK parameters of GS1-144: elimination rate constant (Ξ»z).
β. Trial participants with abnormal findings in physical examination, chest X-ray, abdominal and urinary ultrasound, genital ultrasound, thyroid and parathyroid ultrasound, or laboratory tests at screening, which are deemed unsuitable for participation by the investigator.
β. During screening or on D-1, any of the following liver function test results as follows: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) β₯ 1.5 Γ upper limit of normal (ULN), or total bilirubin (TBIL) β₯ 1.2 Γ ULN.
β. Abnormal vital signs and deemed unsuitable for participation by the investigator, or systolic blood pressure β₯ 150 mmHg and/or diastolic blood pressure β₯ 100 mmHg during screening.