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This multi-center, open-label, parallel-controlled, single-dose Phase 1 study is being conducted to directly characterize the pharmacokinetic (PK) profiles and safety of Jaktinib following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to healthy matched control subjects with normal hepatic function(matched by age, weight, and sex).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A:Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) will be administered a single dose of Jaktinib Hydrochloride Tablets. |
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| Cohort B:Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) will be administered a single dose of Jaktinib Hydrochloride Tablets. |
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| Cohort C:Normal Hepatic Function | Experimental | Participants with normal hepatic function matched to participants with hepatic impairment in Cohorts A and B (matched with regards to age, sex, body mass index) will be administered a single oral dose of Jaktinib Hydrochloride Tablets. |
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| Cohort D:Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 11, inclusive) will be administered a single dose of Jaktinib Hydrochloride Tablets. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib Hydrochloride Tablets | Drug | A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]of Jaktinib and its metabolites(ZG0244 and ZG0245) | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) | From day 1 to day 3 |
| Maximum Observed Plasma Concentration (Cmax) of Jaktinib and its metabolites(ZG0244 and ZG0245) | To evaluate Maximum Observed Plasma Concentration (Cmax) of Jaktinib and its metabolites(ZG0244 and ZG0245) | From day 1 to day 3 |
| Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of Jaktinib and its metabolites(ZG0244 and ZG0245) | The AUC (0-infinity) is the area under the plasma Jaktinib and its metabolites(ZG0244 and ZG0245)concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z) | From day 1 to day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious AEs | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
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Inclusion Criteria:
Additional Inclusion Criteria for Hepatic Impaired Subjects Only:
Additional Inclusion Criteria for Healthy Subjects Only:
Exclusion Criteria:
Exclusion Criteria for Healthy Subjects Only:
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| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao, PhD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Weifeng Zhao, PhD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39442386 | Derived | Zhao M, Zhang H, Ma S, Gong S, Wei C, Miao L, Zhao W. Clinical pharmacokinetic characteristics of Jaktinib in subjects with hepatic impairment in a phase I trial. Drug Metab Pharmacokinet. 2024 Dec;59:101030. doi: 10.1016/j.dmpk.2024.101030. Epub 2024 Jul 20. |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Screening up to follow-up (7 days after dose administration) |