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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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Open-label, parallel, 2-arm, fixed-sequence study to investigate the effect of coadministration of a CYP3A4 inhibitor (Cohort 1, itraconazole multiple dose) and CYP3A4 inducer (Cohort 2, rifampin multiple dose) on the plasma PK of a single dose of KBP-5074 in healthy male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Effects of CYP3A4 inhibition on KBP-5074) | Experimental |
| |
| Cohort 2 (Effects of CYP3A4 induction on KBP-5074) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | 200 mg itraconazole, given orally as 20 mL × 10-mg/mL solution BID on Day 15, followed by QD dosing on Days 16 through 23, inclusive. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter: Maximum observed concentration (Cmax) | Maximum observed concentration (Cmax) - Plasma | Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 hours postdose. |
| Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞) | Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma | Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 hours postdose. |
| Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) | Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma | Days 1 and 19 at predose (Cohort 1) and Days 1 and 21 at predose (Cohort 2) and at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 240 hours postdose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James McCabe | KBP Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS Missouri | Springfield | Missouri | 65802 | United States |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| C000716354 | KBP-5074 |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Rifampin | Drug | 600 mg rifampin, given orally as 2 × 300-mg capsules QD on Days 15 through 25, inclusive. |
|
| KBP-5074 | Drug | 0.5 mg KBP-5074, given orally as 1 × 0.5-mg tablet on Days 1 and 19 or Days 1 and 21 |
|
| 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 |