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This is a phase I study to assess the effect of itraconazole and rifampicin on the pharmacokinetic parameters of BPI-7711 in Chinese healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole and BPI-7711 | Experimental | BPI-7711 alone followed by BPI-7711 +Itraconazole, followed by Itraconazole alone. |
|
| Rifampicin and BPI-7711 | Experimental | BPI-7711 alone followed by BPI-7711 +Rifampicin, followed by Rifampicin alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPI-7711 | Drug | BPI-7711 60 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetics of BPI-7711 by assessment of maximum plasma concentration | Blood samples collected on Day 1 and Day 20 (arm 1)/Day 25 (arm 2) at pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 and 336 hours post BPI-7711 dose |
| AUC(0-last) | Pharmacokinetics of BPI-7711 by assessment of area under the plasma concentration time curve from zero to last assessed timepoint | Blood samples collected on Day 1 and Day 20 (arm 1)/Day 25 (arm 2) at pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 and 336 hours post BPI-7711 dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingying Jia | Shanghai Xuhui Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | 200000 | China |
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| ID | Term |
|---|---|
| C000728929 | rezivertinib |
| D017964 | Itraconazole |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| BPI-7711 | Drug | BPI-7711 180 mg |
|
|
| Itraconazole | Drug | Itraconazole 200 mg |
|
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| Rifampicin | Drug | Rifampicin 600 mg |
|
|
| 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 |