Hepatic Impairment and Healthy FemalePhase 1NCT07491289
GS1-144 in Participants With Hepatic Impairment and Healthy Female
A Phase 1 study testing GS1-144 tablet in people with Hepatic Impairment and Healthy Female, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
GS1-144 in Participants with Hepatic Impairment and Healthy Female Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment and Healthy Female
- What is being tested?
- GS1-144 tablet
- 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 Apr 2026to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who sign the ICF prior to the trial, have a full understanding of the trial content, procedures, and possible adverse reactions, and are able to complete the study in accordance with the protocol requirements。
- Female participants aged 18-70 years (inclusive) (age-matched between the normal hepatic function group and the hepatic impairment groups, mean ±10 years).
- Females of childbearing potential who are willing to use adequate and effective contraception from the date of signing the ICF until 1 month after administration of the investigational drug.
- Body weight ≥ 45.0 kg (body weight matched between the normal hepatic function group and the hepatic impairment groups, mean body weight ±10 kg), with BMI within 18.0-32.0 kg/m2 (inclusive).
- For participants with normal hepatic function, findings from physical examination, vital signs, clinical laboratory tests (hematology, blood chemistry, urinalysis, coagulation tests, thyroid function test [FT3, FT4, and TSH], and parathyroid hormone), Chest x-ray (PA), abdominal ultrasound examinations, etc., are normal or abnormal without clinical significance.
- For participants with hepatic impairment, the following inclusion criteria must also be met to be eligible for this study:
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- Hepatic impairment caused by hepatitis B, hepatitis C, autoimmune hepatitis, nonalcoholic fatty liver disease, alcoholic liver disease, etc., with Child-Pugh classification assessed as Class A/mild (Child-Pugh score: 5-6) or Class B/moderate (Child-Pugh score: 7-9)
- A stable medication regimen for the treatment of hepatic impairment, complications, and/or other concomitant diseases for at least 14 days prior to screening, with no need for modification (e.g., medication type, dose, or dosing frequency); or not receiving medication.
- Clinical laboratory tests: absolute neutrophil count (ANC) ≥ 1.0 × 109/L (1,000/mm3), platelets (PLT) ≥ 35.0 × 109/L (35,000/mm3), hemoglobin (HGB) ≥ 8.0 g/dL (80 g/L), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal (ULN), creatinine clearance (CLcr, calculated using the Cockcroft-Gault formula) ≥ 60 mL/min.
- Systolic blood pressure 90-159 mmHg (Inclusive), diastolic blood pressure 60-99 mmHg (inclusive), and pulse rate 50-100 beats per minute (bpm, inclusive).
Who cannot join
- Allergic constitution (e.g., allergy to more than two drugs or foods), or a history of allergy to the investigational drug or any excipients thereof.
- Use of tobacco-containing products, nicotine, or nicotine-containing products (e.g., e-cigarettes) within 1 month prior to screening, or unwillingness to stop smoking during the study.
- Alcohol abuse within 3 months prior to screening (weekly consumption ≥ 14 units of alcohol: 1 unit = 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or unwillingness to stop drinking during the study.
- Blood loss or donation of ≥ 450 mL of whole blood or plasma within 3 months prior to screening, or receipt of any transfusion of blood or blood products within 60 days.
- Use of CYP1A2 inducers or CYP1A2 inhibitors within 1 month or within 5 half-lives prior to screening (whichever is longer), and throughout the study (except stable concomitant medications for participants with hepatic impairment).
- Use of any of the following drugs within 1 month or within 5 half-lives prior to screening (whichever is longer) (including vitamins, hormonal contraceptives, hormone replacement therapy [HRT], and traditional Chinese medicines, herbal medicines, and Chinese patent medicines [e.g., St. John's wort]), except for occasional use of acetaminophen (≤ 2 g/day), topical dermatologic medications (including corticosteroids), and stable concomitant medications for participants with hepatic impairment.
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- Clinically significant abnormal 12-lead ECG findings [e.g., tachycardia/bradycardia requiring drug treatment, second- to third-degree atrioventricular block, or QTcF > 470 ms (corrected by Fridericia's formula), or other clinically significant abnormalities], and deemed by the investigator as unsuitable for participation.
- Participation in any clinical study within 3 months or within 5 half-lives prior to screening (whichever is longer) (except those who did not receive treatment).
- Severe infection, trauma, gastrointestinal surgery, portosystemic shunt, or other major surgeries within 4 weeks prior to screening.
- Pregnancy, lactation, or a positive serum pregnancy test.
- Consumption of excessive amounts of tea, coffee, or caffeinated beverages (≥8 cups per day; 1 cup = 250 mL) within 3 months prior to screening; or intake of any food or beverage containing caffeine or xanthine, or that may produce caffeine or xanthine metabolites after ingestion (e.g., coffee, tea, chocolate, cola) within 1 day prior to dosing.
- Positive urine drug screening (including morphine, methamphetamine, ketamine, 3,4-methylenedioxymethamphetamine [MDMA], tetrahydrocannabinolic acid, or cocaine). Positive alcohol breath test.
- Any other condition deemed by the investigator to make the participant unsuitable for participation in this study.
- Participants with normal hepatic function with a history or current serious disease of the gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, immune, psychiatric, or cardio-cerebrovascular systems.
- Participants with normal hepatic function who test positive for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or TP Ab.
- participants with hepatic impairment with History of liver transplantation.
- participants with hepatic impairmen with liver failure or drug-induced liver injury, or with hepatic encephalopathy, hepatocellular carcinoma (except BCLC stage 0), esophageal and gastric variceal rupture bleeding, or other cirrhosis-related complications deemed by the investigator as unsuitable.
- participants with hepatic impairmen in addition to the primary liver disease, a history or current serious disease of the gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, immune, psychiatric, cardiovascular, or cerebrovascular systems, or clinically significant laboratory or other test abnormalities that, in the opinion of the investigator, would make them unsuitable for participation.
- participants with hepatic impairmen with positive HIV antigen/antibody screening; if TP Ab is positive, an additional RPR test is required; if the RPR is also positive, the participant must be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pharmacokinetic Study of GS1-144 Tablets in Female Participants With Hepatic Impairment and Healthy Female Participants
GS1-144 in Participants with Hepatic Impairment and Healthy Female
Read the detailed description
Pharmacokinetic Study of GS1-144 Tablets in Female Participants with Hepatic Impairment and Healthy Female Participants
- Conditions
- Hepatic Impairment and Healthy Female
- Being tested
- GS1-144 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS1-144 tabletDrug
Administered a single oral dose with GS1-144 tablet 30mg
| Study group | Role | What they receive |
|---|---|---|
| GS1-144 tablet | Experimental | Not described Receives: Drug: GS1-144 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of GS1-144 Cmax will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
Area under the curve from time 0 to the last time with quantifiable concentration (AUC0-t ) of GS1-144 AUC0-t will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
Area under the curve from time 0 to infinity (AUC0-∞) of GS1-144 AUC0-∞ will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
Time to maximum concentration (Tmax) of GS1-144 Tmax will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
elimination half-life (t1/2) of GS1-144 t1/2 will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
apparent clearance (CL/F) of GS1-144 CL/F will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
Secondary outcomes (10)
Apparent volume of distribution (Vz/F) of GS1-144 Vz/F will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
Cmax of metabolite M1. Cmax of metabolite M1 will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
AUC0-t of metabolite M1. AUC0-t of metabolite M1 will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
AUC0-∞ of metabolite M1. AUC0-∞ of metabolite M1 will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
Tmax of metabolite M1. Tmax of metabolite M1 will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
t1/2 of metabolite M1. t1/2 of metabolite M1 will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
Cmax,u of the plasma unbound fraction (Fu) of GS1-144 and its metabolite M1. Cmax,u will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
AUC0-t,u of the plasma unbound fraction (Fu) of GS1-144 and its metabolite M1. AUC0-t,u will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
AUC0-∞,u. of the plasma unbound fraction (Fu) of GS1-144 and its metabolite M1. AUC0-∞,u. will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
Adverse events (AEs) of GS1-144 Adverse events (AEs), will be assessed and reported.
Measured: From time of taking the GS1-144 up to day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start20 Apr 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Impairment and Healthy FemaleStudies 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 (estimated)
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
- NCT07491289
- Sponsor's protocol ID
- GenSci074-105
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of GS1-144 Tablets in Female Participants With Hepatic Impairment and Healthy Female Participants
- ClinicalTrials.gov ID
- NCT07491289
- Acronym / sponsor ID
- GenSci074-105
- Conditions
- Hepatic Impairment and Healthy Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Mar 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.
GS1-144 in Participants with Hepatic Impairment and Healthy Female
Detailed description
Pharmacokinetic Study of GS1-144 Tablets in Female Participants with Hepatic Impairment and Healthy Female 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 tablet | Experimental | Drug: GS1-144 tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants who sign the ICF prior to the trial, have a full understanding of the trial content, procedures, and possible adverse reactions, and are able to complete the study in accordance with the protocol requirements。
- Female participants aged 18-70 years (inclusive) (age-matched between the normal hepatic function group and the hepatic impairment groups, mean ±10 years).
- Females of childbearing potential who are willing to use adequate and effective contraception from the date of signing the ICF until 1 month after administration of the investigational drug.
- Body weight ≥ 45.0 kg (body weight matched between the normal hepatic function group and the hepatic impairment groups, mean body weight ±10 kg), with BMI within 18.0-32.0 kg/m2 (inclusive).
- For participants with normal hepatic function, findings from physical examination, vital signs, clinical laboratory tests (hematology, blood chemistry, urinalysis, coagulation tests, thyroid function test [FT3, FT4, and TSH], and parathyroid hormone), Chest x-ray (PA), abdominal ultrasound examinations, etc., are normal or abnormal without clinical significance.
Key exclusion criteria (19 listed)
- Allergic constitution (e.g., allergy to more than two drugs or foods), or a history of allergy to the investigational drug or any excipients thereof.
- Use of tobacco-containing products, nicotine, or nicotine-containing products (e.g., e-cigarettes) within 1 month prior to screening, or unwillingness to stop smoking during the study.
- Alcohol abuse within 3 months prior to screening (weekly consumption ≥ 14 units of alcohol: 1 unit = 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or unwillingness to stop drinking during the study.
- Blood loss or donation of ≥ 450 mL of whole blood or plasma within 3 months prior to screening, or receipt of any transfusion of blood or blood products within 60 days.
- Use of CYP1A2 inducers or CYP1A2 inhibitors within 1 month or within 5 half-lives prior to screening (whichever is longer), and throughout the study (except stable concomitant medications for participants with hepatic impairment).
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 tabletAdministered a single oral dose with GS1-144 tablet 30mg | Drug | GS1-144 tablet |
Primary outcome
Maximum concentration (Cmax) of GS1-144 Cmax will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
Area under the curve from time 0 to the last time with quantifiable concentration (AUC0-t ) of GS1-144 AUC0-t will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
Area under the curve from time 0 to infinity (AUC0-∞) of GS1-144 AUC0-∞ will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
Time to maximum concentration (Tmax) of GS1-144 Tmax will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
elimination half-life (t1/2) of GS1-144 t1/2 will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
apparent clearance (CL/F) of GS1-144 CL/F will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
10 secondary outcomes
Apparent volume of distribution (Vz/F) of GS1-144 Vz/F will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
Cmax of metabolite M1. Cmax of metabolite M1 will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
AUC0-t of metabolite M1. AUC0-t of metabolite M1 will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
AUC0-∞ of metabolite M1. AUC0-∞ of metabolite M1 will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
Tmax of metabolite M1. Tmax of metabolite M1 will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
t1/2 of metabolite M1. t1/2 of metabolite M1 will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
Cmax,u of the plasma unbound fraction (Fu) of GS1-144 and its metabolite M1. Cmax,u will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
AUC0-t,u of the plasma unbound fraction (Fu) of GS1-144 and its metabolite M1. AUC0-t,u will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
AUC0-∞,u. of the plasma unbound fraction (Fu) of GS1-144 and its metabolite M1. AUC0-∞,u. will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
Adverse events (AEs) of GS1-144 Adverse events (AEs), will be assessed and reported.
Time frame: From time of taking the GS1-144 up to day 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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.
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 tablet in people with Hepatic Impairment and Healthy Female, 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 19 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: opening soon, as of the sponsor's last update on 24 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Zhang (+86 18186870853, jhongzhang@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration (Cmax) of GS1-144 Cmax will be assessed and reported. (time frame: From time of taking the GS1-144 up to day 4). The study lists 6 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 24 Mar 2026.