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Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111
This is a Phase 1 open-label, parallel-group study in healthy subjects. Subjects in Part A will receive a single dose of BGB-3111 before and during consecutive daily doses of strong cytochrome P450 CYP3A inducer, rifampin, to investigate its effect on the pharmacokinetics of BGB-3111. Following an interim data analysis, subjects in Part B will receive a single dose of BGB-3111 before and during consecutive daily doses of strong CYP3A inhibitor, itraconazole, to investigate its effect on the pharmacokinetics of BGB-3111.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Approximately 20 subjects to receive BGB-3111 and rifampin |
|
| Arm B | Experimental | Approximately 20 subjects to receive BGB-3111 and itraconazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-3111 (Arm A) | Drug | 320 mg BGB-3111 single oral dose |
| |
| Rifampin |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters | Part A: Days 1 and 10 | |
| Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters | Part B: Days 1 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by adverse events | Part A: up to 19 days: Part B: up to 14 days | |
| Safety as assessed by electrocardiogram (ECG) measurements | Part A: Days 1 and 10, from screening to end of study visit; up to Day 19; Part B: Days 1 and 6, from screening to end of study visit; up to Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Novotny, MD | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials (WCCT) | Cypress | California | 90630 | United States |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| 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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| Drug |
600 mg rifampin once daily |
|
|
| BGB-3111 (Arm B) | Drug | Up to 80 mg BGB-3111 single oral dose |
|
| Itraconazole | Drug | 200 mg itraconazole once daily |
|
|
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |