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This is a phase I, single-center, open-label, fixed-sequence clinical study. The primary objective was to evaluate the effects of multiple administrations of rifampin or itraconazole on the pharmacokinetic characteristics of a single administration of orelabrutinib tablets in healthy Chinese subjects. The secondary objective was to evaluate the safety and tolerability of rifampicin or itraconazole combined with orelabrutinib tablets in healthy Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orelabrutinib + Rifampin | Other | Orelabrutinib is a white, round, uncoated table,Subjects take high dose orelabrutinib in the first day and the tenth day. Rifampin is a capsule,Subjects take 600mg QD rifampin in the third day to the eleventh. |
|
| Orelabrutinib + Itraconazole | Other | Orelabrutinib is a white, round, uncoated table,Subjects take low dose orelabrutinib in the first day and the eighth day. Itraconazole is a capsule,Subjects take 600mg QD rifampin in the third day to the tenth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orelabrutinib + Rifampin | Drug | Orelabrutinib + Rifampin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include the peak plasma concentration (Cmax) | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | To preliminarily obtain pharmacokinetic (PK) data of Orelabrutinib in the treatment of advanced solid tumors include Time to Maximum Plasma Concentration(Tmax) | up to 3 months |
| Incidence of Treatment-Emergent Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
| D012293 | Rifampin |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Orelabrutinib + Itraconazole |
| Drug |
Orelabrutinib + Itraconazole |
|
To evaluate the safety and tolerability of Orelabrutinib
| up to 3 months |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |