BridgeMD
New treatment option for Postmenopause
Official title To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets .
ClinicalTrials.gov ID: NCT07534176
What this study is testing
What is GS1-144 tablets?
GS1-144 tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for postmenopause.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- 1)40 to 65 years of age (inclusive) at the time of signing the informed consent form (ICF). 2)Trial participants are healthy females who meet any of...
- Consecutive spontaneous amenorrhea ≥ 12 months.
- Consecutive spontaneous amenorrhea ≥ 6 months but \ 40 IU/L.
- ≥ 6 weeks after bilateral oophorectomy.
- History of hysterectomy with preservation of one or both ovaries and FSH levels \> 40 IU/L. 3)Body weight ≥ 45 kg, and body mass index (BMI) within...
You likely can't join if
- Known history of hypersensitivity to the investigational drug, any of its excipients, or related formulations; or a history of allergic disorders...
- History or current diagnosis of diseases of the circulatory, digestive, urinary, respiratory, endocrine and metabolic, hematological and lymphatic...
- 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...
- Use of any prescription medications [including but not limited to drugs known to alter hepatic enzyme activity (e.g., glucocorticoids, sex hormones...
- Trial participants with abnormal findings in physical examination, chest X-ray, abdominal and urinary ultrasound, genital ultrasound, thyroid and...
See the full eligibility criteria
- 1)40 to 65 years of age (inclusive) at the time of signing the informed consent form (ICF). 2)Trial participants are healthy females who meet any of the following criteria during screening:
- Consecutive spontaneous amenorrhea ≥ 12 months.
- Consecutive spontaneous amenorrhea ≥ 6 months but \ 40 IU/L.
- ≥ 6 weeks after bilateral oophorectomy.
- History of hysterectomy with preservation of one or both ovaries and FSH levels \> 40 IU/L. 3)Body weight ≥ 45 kg, and body mass index (BMI) within the range of 18-28 kg/m2 (inclusive). 4)Able to communicate well with...
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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.
- Abnormal 12-lead ECG findings and deemed unsuitable for participation by the investigator, or QTcF \> 470 ms (Fridericia's formula: QTcF = QT/RR0.33, RR = 60/heart rate) during screening.
- Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (TP-Ab) during screening.
- Participation in another clinical trial within 3 months prior to screening (except for trial participants who did not receive any investigational intervention), or current participation in any other clinical trial.
- Current or past history of drug abuse within 1 year, or positive urine multi-drug test panel.
- Positive alcohol breath test or history of excessive alcohol consumption (defined as \>14 units of alcohol per week) within 3 months prior to screening (One standard alcohol unit is equivalent to 17.5 mL or 14 g of pure...
- Consumption of food or beverages that may affect drug metabolism (e.g., containing grapefruit, starfruit, or their products) within 48 hours prior to admission.
- Excessive consumption of tea, coffee, or caffeinated beverages (\>8 cups per day, 1 cup=250 mL) within 3 months prior to screening; or consumption of any food or beverage containing or metabolized to caffeine or...
- Pregnant or lactating women, or those who have a clinically significant positive pregnancy test result.
- Poor venous access, a history of difficult venipuncture, intolerance to venipuncture/intravenous indwelling needle, or needle/blood phobia.
- Other conditions deemed unsuitable by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shandong, Jinan, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shandong, Jinan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.