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This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of metabolic enzyme inhibitors/inducers on in vivo metabolic and elimination of TQ05105 tablets, and the safety of metabolic enzyme inhibitors/inducers combined with TQ05105 tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole drug-durg interaction (DDI) | Experimental | Itraconazole capsule: 0.2g once daily on Days 2 to Day 5; TQ05105 tablets: single oral dose on Days 1 and Day 5. |
|
| Rifampicin DDI | Experimental | Rifampicin Capsule: 0.6g once daily on Days 2 to Day 9; TQ05105 tablets: single oral dose on Days 1 and Day 9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ05105 tablets | Drug | TQ05105 is a Janus kinase 2 (JAK2) inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Maximum plasma drug concentration after administration. | Up to 10 days. |
| Time to reach Cmax (Tmax) | Time to reach the maximum plasma concentration after administration. | Up to 10 days. |
| Elimination half-life (t1/2) | The elimination half-life (t1/2) after oral dose of TQ05105 tablets and Itraconazole capsule. | Up to 6 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events (AE) | Including all adverse events (AE) and serious adverse events (SAE). | Up to 30 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | 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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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole capsule | Drug | Itraconazole is a strong inhibitor of cytochrome P450 3A (CYP3A). |
|
| Rifampicin Capsule | Drug | Rifampicin is a strong inducer of CYP3A. |
|
| D010879 |
| Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |