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TQ05105 is a class 1 new drug with a new chemical structure developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. It is a Janus Kinase 2 (JAK2)inhibitor and can be used to treat JAK2 target-related diseases. This study is a randomized, open-label, single-center, two-cycle, two-crossover Phase I clinical trial evaluating the effect of food on the pharmacokinetics of TQ05105 tablets in healthy adult subjects. Pharmacokinetic effects and safety after oral administration of TQ05105 tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ05105 Tablets (fasted) | Experimental | TQ05105 tablets was administered on fasted state in the first cycle for Group A and the second cycle for Group B. |
|
| TQ05105 Tablets (fed) | Experimental | TQ05105 tablets was administered on fed state in the second cycle for Group A and the first cycle for Group B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ05105 Tablets | Drug | TQ05105 tablet is a novel JAK2 inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the drug-time curve (AUC) | Area under the drug-time curve | 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration |
| Maximum Concentration (Cmax) | Maximum concentration | 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration following drug administration (Tmax) | Time to maximum concentration following drug administration | 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration |
| Apparent terminal elimination half-life following drug administration (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Changchun University of Traditional Chinese Medicine | Changchun | Jilin | 130103 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39924599 | Derived | Dai J, Cheng Y, Zhou Y, Wang Y, Liu Z, Ren Q, Su Z, Deng Q, Yang H, Cui Y. Food effect trial of the pharmacokinetics and safety of TQ05105 in healthy Chinese subjects. Cancer Chemother Pharmacol. 2025 Feb 10;95(1):31. doi: 10.1007/s00280-025-04754-z. |
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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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Apparent terminal elimination half-life following drug administration |
| 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration |
| Apparent volume of distribution (Vd/F) | Apparent volume of distribution | 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration |
| Clearance rate (CL/F) | Clearance rate | 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 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 24 hours after administration |
| Body temperature | Monitor the safety indicators of subjects during the trial | 1 hour before administration and 1, 4, 12, 24 hours after administration |
| Pulse | Monitor the safety indicators of subjects during the trial | 1 hour before administration and 1, 4, 12, 24 hours after administration |
| Blood pressure | Monitor the safety indicators of subjects during the trial | 1 hour before administration and 1, 4, 12, 24 hours after administration |