To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets . (NCT07534176) | Clinical Trial Compass
RecruitingPhase 1
To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets .
China24 participantsStarted 2026-05-20
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 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
. Consecutive spontaneous amenorrhea ≥ 12 months.
. Consecutive spontaneous amenorrhea ≥ 6 months but \< 12 months, with serum follicle-stimulating hormone (FSH) levels \> 40 IU/L.
. ≥ 6 weeks after bilateral oophorectomy.
. History of hysterectomy with preservation of one or both ovaries and FSH levels \> 40 IU/L.
Exclusion criteria
. 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).
. 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.
. History of severe infection, serious trauma, or major surgery within 6 months prior to screening, or planning to undergo surgery during the trial.
. Blood donation or blood loss ≥ 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.
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
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-∞.
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 (λz).
. 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.
. 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.
. During screening or on D-1, any of the following liver function test results as follows: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 1.2 × ULN.
. Abnormal vital signs and deemed unsuitable for participation by the investigator, or systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg during screening.