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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control | Experimental | Each healthy participant will receive a single dose of GP681 |
|
| Mild, Child-Pugh A | Experimental | Each participant with Child-Pugh A will receive a single dose of GP681 |
|
| Moderate; Child-Pugh B | Experimental | Each participant with Child-Pugh B will receive a single dose of GP681 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GP681 | Drug | GP681, tablet, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of the analyte in plasma after oral administration of GP681 | 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 | 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 | Day 1 to Day12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cmax (Tmax) of the analyte in plasma | Day 1 to Day12 | |
| Terminal elimination half-life (t1/2) of the analyte in plasma | Day 1 to Day12 | |
| Apparent Clearance (CLz/F) of the analyte in plasma |
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Inclusion Criteria:
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:
Exclusion Criteria:
Participants with Hepatic Impairment Only:
Participants with Normal Hepatic Function Only:
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| Name | Affiliation | Role |
|---|---|---|
| Haibin Yu | Beijing YouAn Hospital | Principal Investigator |
| Bin Xu | Beijing YouAn Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing You'an Hospital, Beijing Medical University | Beijing | Beijing Municipality | 100069 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41870058 | Derived | 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. |
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| Day 1 to Day12 |
| Apparent volume of distribution (Vz/F) of the analyte in plasma | Day 1 to Day12 |
| Number of participants with drug-related adverse events as assessed by CTCAE v5.0 | Day 1 to Day12 |