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AB-106-C110 is China-only study, for investigating the drug interaction between AB-106 and CYP3A4 inhibitor (Itraconazole)/CYP3A4 inducer (Rifampin)(n=56)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole cohort | Experimental |
| |
| Rifampicin cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB-106, Itraconazole | Drug | single dose AB-106 at Day1, Itraconazole QD at Day14~Day28, single dose AB-106 at Day17 |
|
| Measure | Description | Time Frame |
|---|---|---|
| AB-106 PK Exposure Parameters | Peak Plasma Concentration (Cmax) | 29 days |
| AB-106 PK Exposure Parameters | Area under the plasma concentration versus time curve (AUC) | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| AB-106 PK Parameters | Time to drug peak plasma concentration (Tmax) | 29 days |
| AB-106 PK Parameters | Percentage of area under the curve from time of the last quantifiable concentration to infinity to area under the curve to infinity (AUC_extr%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital of Capital Medical University | Beijing | China |
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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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| AB-106, Rifampicin | Drug | single dose AB-106 at Day1, Itraconazole QD at Day14~Day32, single dose AB-106 at Day21 |
|
| 29 days |
| AB-106 PK Parameters | Lambda_z, first-order rate constant associated with the terminal portion of the curve (λz) | 29 days |
| AB-106 PK Parameters | Terminal phase elimination half life (t1/2) | 29 days |
| AB-106 PK Parameters | Apparent total clearance (CL/F) | 29 days |
| AB-106 PK Parameters | Apparent volume of distribution (Vz/F) | 29 days |
| Safety Assessment | Adverse events (AEs) | 47 days |
| 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 |