Healthy VolunteersPhase 1NCT05814926
GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
A Phase 1 study testing GP681 in people with Healthy Volunteers and Hepatic Impairment, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to test whether mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment affects pharmacokinetics, safety and tolerability of GP681, compared with a control group with normal hepatic function following oral administration of GP681 as single dose. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Hepatic Impairment
- What is being tested?
- GP681
- 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
- 26 Apr 2023to 20 Oct 2023
- 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 18 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants，between the ages of 18 and 68 years of age (inclusive) at the time of Screening;
- Body weight ≥50 kg for males, ≥45kg for females, and body mass index (BMI) between18-30 kg/m^2(inclusive);
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.
- Participants with Hepatic Impairment Only:
- Participants must satisfy the criteria for primary liver disease as evidenced by a Child-Pugh A (score 5-6), B (score 7-9). Treatment-naïve participants for at least 4 weeks before screening can be entered into the study. Unless otherwise stated, participants must have been on stable doses and regimens of the concomitant medication for at least 4 weeks before screening.
- Participants with Normal Hepatic Function Only:
Show all 11Show fewer
- Healthy participants, between the ages of 18 and 68 years of age (inclusive) at the time of Screening, matched to participants with hepatic impairment with regard to age (+/-10 years), and gender(+/-1 subject);
- Body weight ≥50 kg for males, ≥45kg for females, and body mass index (BMI) between18-30 kg/m^2(inclusive), matched to participants with hepatic impairment with regard to body weight (+/-25% kg);
- In good health, determined by no clinically significant findings from vital signs, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory evaluations, and other safety examinations at screening, as assessed by the investigator.
- Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 3 months after the final dose of study drug
- Adequate hepatic function within 14 days before drug administration defined as: AST or ALT ≤ 1.5 times the upper limit of normal values, total bilirubin within normal limits.
Who cannot join
- History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to drugs. Those who cannot follow a uniform diet for special dietary requirements.
- History of seizure，including any febrile seizure, or transient ischemic attack, or any condition that may pre-dispose to seizure (such as prior stroke, brain arteriovenous malformation, brain trauma with requiring hospitalization, and lacunar cerebral infarction).
- Have a malignant tumor or a history of malignant tumor in the 5 years prior to screening (except for patients with non-melanoma skin cancers with no evidence of recurrence, or patients with excised cervical intraepithelial neoplasia).
- Subjects with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening;
- Abnormal blood pressure response, or clinically significant abnormal blood pressure assessed by the investigator.
- Having a history of clinically significant ECG abnormalities (history of tachycardia/bradycardia requiring medical therapy, II-III degree atrioventricular block, or QTcF>450ms for males，>460ms for females(corrected by Fridericia's formula), or other clinically significant abnormals assessed by the investigator.
Show all 32Show fewer
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, according to the modification of diet in renal disease equation.
- Those who plan to undergo surgery, or intent to intent to be hospitalized during the trial.
- A positive test for HIV antibody at screening.
- Received any drugs that inhibit or induce the CYP450 enzyme (i.e., phenytoin, rifampin, carbamazepine, fluvoxamine, enoxacin, ticlopidine, gemfibrozil, clopidogrel, clarithromycin, itraconazole, ketoconazole, ritonavir) 4 weeks prior to screening period.
- Received any drugs (including Chinese herbal medicine, vitamins and supplements) within 14 days or 5-half-lives (which is longer) prior to dosing;
- Participation in another clinical trial within 3 months before dosing.
- Those who have lost blood or donated up to 200 mL within 3 months before dosing, or those who plan to donate blood within 1 month after the end of this study.
- Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period.
- Average weekly intake of alcohol is more than 14 units alcohol (1 units ≈ 360 mL beer, or 45 mL spirits with 40% content, or 150 mL wine) within the 6 months prior to dosing, or a positive ethanol breath test at screening.
- Substance abuse or use of soft drugs (e.g., marijuana) or use of hard drugs (e.g., cocaine, amphetamines, phenylcyclohexidine, etc.); Or screening for positive urine drug abuse (drug) tests.
- Habitual or excessive consumption (more than 8 cups, 1cup=250mL) of grapefruit juice, tea, coffee and/or caffeinated beverages.
- Subjects who are intolerant to venipuncture or have a history of fainting blood or acupuncture.
- Those who have received vaccine within 1 month before screening.
- Pregnant or lactating women, or those with positive blood pregnancy tests.
- Male or female subjects of childbearing age agreed to take effective and safe contraception during treatment and 3 months after treatment.
- Subjects with poor compliance, or not suitable for this study as judged by the investigator.
- Participants with Hepatic Impairment Only:
- Have received liver transplant at any time in the past.
- Patients complicated with drug-induced liver injury.
- Other causes of acute liver injury.
- Patients with liver failure, or combined with hepatic encephalopathy, hepatocellular carcinoma, and esophageal and gastric variceal bleeding and other complications considered by the investigator as unsuitable for the clinical study.
- Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, or hematological, immune, psychiatric, and metabolic disorders.
- Participants with Normal Hepatic Function Only:
- Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, or hematological, immune, psychiatric, and metabolic disorders.
- Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.
- Positive result of any indicators of hepatitis B surface antigen, hepatitis C antibody within 1 week prior to screening or at screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing You'an Hospital, Beijing Medical University
Beijing, Beijing Municipality, 100069
About this study
Official title: Pharmacokinetics, Safety and Tolerability of GP681 Single Oral Dose in Male and Female Patients With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) as Compared With GP681 Administration to Male and Female Healthy Subjects
The primary objective of this study is to test whether mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment affects pharmacokinetics, safety and tolerability of GP681, compared with a control group with normal hepatic function following oral administration of GP681 as single dose.
Read the detailed description
This is a multicenter, open-label, parallel group, single-dose study to compare pharmacokinetics of GP681 after a single 40mg oral dose in eight healthy subjects and eight mild or eight moderate hepatic impairment subjects. Subjects with hepatic impairment will be enrolled into either mild (Child-Pugh A, score 5-6) or moderate (Child-Pugh B, score 7-9) hepatic impairment groups. The healthy subjects will match with impaired hepatic function patients on ethnic group, sex(+/- 1 subject), age (+/- 10 years) and weight (+/- 25%).
Participants will be admitted into the Clinical Research Units(CRU) on Day-1. On the morning of Day 1, subjects will receive a single 40 mg oral dose of GP681 following an overnight fast (i.e., at least 10 hours). Participants will be confined to the CRU until discharge on Day 12, with PK blood sample draws for measurement of GP681 and its main metabolites being taken throughout the confinement.
Safety assessments will include physical examinations, ECGs, vital signs, standard clinical laboratory evaluations (hematology, blood chemistry, urinalysis, coagulation), AE and serious adverse event (SAE) monitoring.
All participants will have a post-study safety follow-up contact conducted approximately 12 days after administration of study treatment. The study will be considered complete once all the participants have finished the required assessments, dropped out, or been lost to follow-up before completing the required assessments.
- Conditions
- Healthy Volunteers, Hepatic Impairment
- Being tested
- GP681
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP681Drug
GP681, tablet, oral
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Experimental | Each healthy participant will receive a single dose of GP681 Receives: Drug: GP681 |
| Mild, Child-Pugh A | Experimental | Each participant with Child-Pugh A will receive a single dose of GP681 Receives: Drug: GP681 |
| Moderate; Child-Pugh B | Experimental | Each participant with Child-Pugh B will receive a single dose of GP681 Receives: Drug: GP681 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of the analyte in plasma after oral administration of GP681
Measured: Day 1 to Day12
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after oral administration of GP681
Measured: Day 1 to Day12
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration of GP681
Measured: Day 1 to Day12
Secondary outcomes (5)
Time to Cmax (Tmax) of the analyte in plasma
Measured: Day 1 to Day12
Terminal elimination half-life (t1/2) of the analyte in plasma
Measured: Day 1 to Day12
Apparent Clearance (CLz/F) of the analyte in plasma
Measured: Day 1 to Day12
Apparent volume of distribution (Vz/F) of the analyte in plasma
Measured: Day 1 to Day12
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Measured: Day 1 to Day12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start26 Apr 2023
- Primary completion3 Aug 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haibin Yu, Principal investigator, Beijing YouAn HospitalBin Xu, Principal investigator, Beijing YouAn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814926
- Sponsor's protocol ID
- GP681-202203
- Status last verified
- Nov 2023
- First submitted
- 4 Apr 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou J, Yan S, Zhao Y, Zhang H, Wang N. A phase I study to evaluate the effect of hepatic impairment on the pharmacokinetics and safety of suraxavir marboxil: a novel oral antiviral for influenza. Antimicrob Agents Chemother. 2026 May 6;70(5):e0166825. doi: 10.1128/aac.01668-25. Epub 2026 Mar 23.
PubMed 41870058
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Safety and Tolerability of GP681 Single Oral Dose in Male and Female Patients With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) as Compared With GP681 Administration to Male and Female Healthy Subjects
- ClinicalTrials.gov ID
- NCT05814926
- Acronym / sponsor ID
- GP681-202203
- Conditions
- Healthy Volunteers, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 18 Apr 2023 (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.
The primary objective of this study is to test whether mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment affects pharmacokinetics, safety and tolerability of GP681, compared with a control group with normal hepatic function following oral administration of GP681 as single dose.
Detailed description
This is a multicenter, open-label, parallel group, single-dose study to compare pharmacokinetics of GP681 after a single 40mg oral dose in eight healthy subjects and eight mild or eight moderate hepatic impairment subjects. Subjects with hepatic impairment will be enrolled into either mild (Child-Pugh A, score 5-6) or moderate (Child-Pugh B, score 7-9) hepatic impairment groups. The healthy subjects will match with impaired hepatic function patients on ethnic group, sex(+/- 1 subject), age (+/- 10 years) and weight (+/- 25%).
Participants will be admitted into the Clinical Research Units(CRU) on Day-1. On the morning of Day 1, subjects will receive a single 40 mg oral dose of GP681 following an overnight fast (i.e., at least 10 hours). Participants will be confined to the CRU until discharge on Day 12, with PK blood sample draws for measurement of GP681 and its main metabolites being taken throughout the confinement.
Safety assessments will include physical examinations, ECGs, vital signs, standard clinical laboratory evaluations (hematology, blood chemistry, urinalysis, coagulation), AE and serious adverse event (SAE) monitoring.
All participants will have a post-study safety follow-up contact conducted approximately 12 days after administration of study treatment. The study will be considered complete once all the participants have finished the required assessments, dropped out, or been lost to follow-up before completing the required assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | Experimental | Drug: GP681Each healthy participant will receive a single dose of GP681 |
| Mild, Child-Pugh A | Experimental | Drug: GP681Each participant with Child-Pugh A will receive a single dose of GP681 |
| Moderate; Child-Pugh B | Experimental | Drug: GP681Each participant with Child-Pugh B will receive a single dose of GP681 |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female participants，between the ages of 18 and 68 years of age (inclusive) at the time of Screening;
- Body weight ≥50 kg for males, ≥45kg for females, and body mass index (BMI) between18-30 kg/m^2(inclusive);
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.
- Participants must satisfy the criteria for primary liver disease as evidenced by a Child-Pugh A (score 5-6), B (score 7-9). Treatment-naïve participants for at least 4 weeks before screening can be entered into the study. Unless otherwise stated, participants must have been on stable doses and regimens of the concomitant medication for at least 4 weeks before screening.
- Healthy participants, between the ages of 18 and 68 years of age (inclusive) at the time of Screening, matched to participants with hepatic impairment with regard to age (+/-10 years), and gender(+/-1 subject);
Key exclusion criteria (32 listed)
- History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to drugs. Those who cannot follow a uniform diet for special dietary requirements.
- History of seizure，including any febrile seizure, or transient ischemic attack, or any condition that may pre-dispose to seizure (such as prior stroke, brain arteriovenous malformation, brain trauma with requiring hospitalization, and lacunar cerebral infarction).
- Have a malignant tumor or a history of malignant tumor in the 5 years prior to screening (except for patients with non-melanoma skin cancers with no evidence of recurrence, or patients with excised cervical intraepithelial neoplasia).
- Subjects with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening;
- Abnormal blood pressure response, or clinically significant abnormal blood pressure assessed by the investigator.
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 |
|---|---|---|
| GP681GP681, tablet, oral | Drug | Healthy Control, Mild, Child-Pugh A, Moderate; Child-Pugh B |
Primary outcome
Peak plasma concentration (Cmax) of the analyte in plasma after oral administration of GP681
Time frame: Day 1 to Day12
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after oral administration of GP681
Time frame: Day 1 to Day12
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration of GP681
Time frame: Day 1 to Day12
5 secondary outcomes
Time to Cmax (Tmax) of the analyte in plasma
Time frame: Day 1 to Day12
Terminal elimination half-life (t1/2) of the analyte in plasma
Time frame: Day 1 to Day12
Apparent Clearance (CLz/F) of the analyte in plasma
Time frame: Day 1 to Day12
Apparent volume of distribution (Vz/F) of the analyte in plasma
Time frame: Day 1 to Day12
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Time frame: Day 1 to Day12
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 15 Nov 2023.
- Derived from this study: PubMed 41870058Zhou J, Yan S, Zhao Y, Zhang H, Wang N. A phase I study to evaluate the effect of hepatic impairment on the pharmacokinetics and safety of suraxavir marboxil: a novel oral antiviral for influenza. Antimicrob Agents Chemother. 2026 May 6;70(5):e0166825. doi: 10.1128/aac.01668-25. Epub 2026 Mar 23.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Haibin Yu principal investigator
Beijing YouAn Hospital
Bin Xu principal investigator
Beijing YouAn Hospital
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 GP681 in people with Healthy Volunteers and Hepatic Impairment, run by Jiangxi Qingfeng 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 11 inclusion and 32 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 15 Nov 2023. 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?
Peak plasma concentration (Cmax) of the analyte in plasma after oral administration of GP681 (time frame: Day 1 to Day12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05814926, which also lists 1 linked publication.
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 15 Nov 2023.