PostmenopausePhase 1NCT07534176
To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets .
A Phase 1 study testing GS1-144 tablets in people with Postmenopause, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause
- What is being tested?
- GS1-144 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 29 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 < 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.
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- 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 the investigator, understand and comply with all study requirements, voluntarily agree to participate in the trial, and understand and voluntarily sign the ICF.
- 5)Smoker:smoking ≥ 10 cigarettes per day within 6 months prior to screening, and urinary cotinine level ≥ 1,000 ng/mL at screening. Smokers will be required to continue smoking in designated areas according to their habits during the study.
- 6)Non-smoker: no smoking within 6 months prior to screening, and urinary cotinine level < 200 ng/mL at screening.
Who cannot join
- 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.
- 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.
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- 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.
- 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 ethanol. Alcohol content is labeled by volume (ABV) for all beverage types. This corresponds approximately to 35 mL of 50% spirits or 350 mL of 5% beer), or unwillingness to abstain from alcohol or any alcohol-containing products during the trial.
- 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 xanthine (e.g., coffee, tea, chocolate, cola) within 24 hours prior to admission.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Shandong, Jinan, 100021
About this study
Official title: 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
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
Read the detailed description
This drug-drug interaction study adopts an open-label, parallel design to evaluate the effect of smoking on the PK following a single oral dose of GS1-144 tablets in Chinese healthy postmenopausal female trial participants.
- Conditions
- Postmenopause
- Being tested
- GS1-144 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS1-144 tabletsDrug
All trial participants will receive the investigational drug (GS1-144 tablets) at a dose of 30 mg.
| Study group | Role | What they receive |
|---|---|---|
| GS1-144 tablets | Experimental | Not described Receives: Drug: GS1-144 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary PK parameters for GS1-144: Cmax.
Measured: up to 72 hours
Primary PK parameters for GS1-144: AUC0-t.
Measured: up to 72 hours
Primary PK parameters for GS1-144: AUC0-∞.
Measured: up to 72 hours
Secondary PK parameters of GS1-144: Tmax.
Measured: up to 72 hours
Secondary PK parameters of GS1-144: elimination rate constant (λz).
Measured: up to 72 hours
Secondary PK parameters of GS1-144: t1/2.
Measured: up to 72 hoursv
Secondary PK parameters of GS1-144:CL/F.
Measured: up to 72 hours
Secondary PK parameters of GS1-144: Vd/F.
Measured: up to 72 hours
Secondary PK parameters of GS1-144: AUC_%Extrap.
Measured: up to 72 hours
Secondary outcomes (8)
PK parameters of the primary metabolite M1: Cmax.
Measured: up to 72 hours
PK parameters of the primary metabolite M1: AUC0-t.
Measured: up to 72 hours
PK parameters of the primary metabolite M1: AUC0-∞.
Measured: up to 72 hours
:PK parameters of the primary metabolite M1: Tmax.
Measured: up to 72 hours
PK parameters of the primary metabolite M1: λz.
Measured: up to 72 hours
PK parameters of the primary metabolite M1: t1/2.
Measured: up to 72 hours
PK parameters of the primary metabolite M1: AUC_%Extrap.
Measured: up to 72 hours
Adverse events (AEs).
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 May 2026
- Primary completion2 Jul 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534176
- Sponsor's protocol ID
- GenSci074-107
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07534176
- Acronym / sponsor ID
- GenSci074-107
- Conditions
- Postmenopause
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2026 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This drug-drug interaction study adopts an open-label, parallel design to evaluate the effect of smoking on the PK following a single oral dose of GS1-144 tablets in Chinese healthy postmenopausal female trial participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GS1-144 tablets | Experimental | Drug: GS1-144 tablets |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 < 12 months, with serum follicle-stimulating hormone (FSH) levels > 40 IU/L.
- ≥ 6 weeks after bilateral oophorectomy.
Key exclusion criteria (18 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS1-144 tabletsAll trial participants will receive the investigational drug (GS1-144 tablets) at a dose of 30 mg. | Drug | GS1-144 tablets |
Primary outcome
Primary PK parameters for GS1-144: Cmax.
Time frame: up to 72 hours
Primary PK parameters for GS1-144: AUC0-t.
Time frame: up to 72 hours
Primary PK parameters for GS1-144: AUC0-∞.
Time frame: up to 72 hours
Secondary PK parameters of GS1-144: Tmax.
Time frame: up to 72 hours
Secondary PK parameters of GS1-144: elimination rate constant (λz).
Time frame: up to 72 hours
Secondary PK parameters of GS1-144: t1/2.
Time frame: up to 72 hoursv
Secondary PK parameters of GS1-144:CL/F.
Time frame: up to 72 hours
Secondary PK parameters of GS1-144: Vd/F.
Time frame: up to 72 hours
Secondary PK parameters of GS1-144: AUC_%Extrap.
Time frame: up to 72 hours
8 secondary outcomes
PK parameters of the primary metabolite M1: Cmax.
Time frame: up to 72 hours
PK parameters of the primary metabolite M1: AUC0-t.
Time frame: up to 72 hours
PK parameters of the primary metabolite M1: AUC0-∞.
Time frame: up to 72 hours
:PK parameters of the primary metabolite M1: Tmax.
Time frame: up to 72 hours
PK parameters of the primary metabolite M1: λz.
Time frame: up to 72 hours
PK parameters of the primary metabolite M1: t1/2.
Time frame: up to 72 hours
PK parameters of the primary metabolite M1: AUC_%Extrap.
Time frame: up to 72 hours
Adverse events (AEs).
Time frame: up to 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS1-144 tablets in people with Postmenopause, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary PK parameters for GS1-144: Cmax. (time frame: up to 72 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.