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This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the safety of the drug in these patients after a single dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Mild hepatic impairment (Child-Pugh A) | Active Comparator | A: 15 mg orally , single dose |
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| B: Moderate hepatic impairment (Child-Pugh B) | Active Comparator | B: 10 mg orally , single dose |
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| C: Normal | Active Comparator | C: 15 mg orally , single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ05105 | Drug | Janus Kinase Inhibitors/Rho-associated Kinase (JAK/ROCK) inhibitors |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Maximum plasma drug concentration of TQ05105 and TQ12550 | Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration |
| Area under the concentration-time curve (AUC) | Area under the plasma concentration-time curve of TQ05105 and TQ12550 | Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-maximum concentration( Tmax) of TQ05105 and TQ12550 | Time-to-maximum concentration | Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration |
| Plasma half life (t1/2) |
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Inclusion Criteria:
Additional Criteria for Participants with Normal Liver Function:
Additional Criteria for Participants with Impaired Liver Function:
Exclusion Criteria:
Additional Exclusions for Normal Liver Function Participants:
Additional Exclusions for Impaired Liver Function Participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhao, Doctor | Contact | 0531-85875449 | zhao4wei2@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Henan University of Science & Technology | Recruiting | Luoyang | Henan | 471000 | China |
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| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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The time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half of TQ05105 and TQ12550
| Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48hours after administration |
| Apparent volume of distribution (Vz/F) | Apparent Volume of Distribution at the Terminal Phase divided by Bioavailability | Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24, 48hours after administration |
| Terminal elimination rate (λz) | First-order rate constant associated with the terminal (log-linear) elimination phase of TQ05105 and TQ12550 | Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after administration |
| Curve extrapolated to infinity (AUC_%Extrap) | Percentage of the Area Under the Curve extrapolated to infinity | Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after administration |
| Apparent Clearance (CL/F) | The apparent volume of plasma from which the drug is completely removed per unit time, adjusted for bioavailability | Before administration, 10, 20, 30, 45 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after administration |
| Fraction unbound(fu%) | The proportion of a drug or substance in the bloodstream that is not bound to plasma proteins and is therefore free to exert pharmacological activity, be metabolized, or undergo elimination. | 0.5, 2, 6 hours after administration |
| Adverse event rate | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). | Baseline up to day7 |
| The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital) | Not yet recruiting | Jinan | Shandong | 250000 | China |
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