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This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all subjects will receive multiple oral doses of the combination danoprevir with ritonavir and efavirenz for 14 days. Anticipated time on study treatment is 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A danoprevir+ritonavir | Active Comparator |
| |
| B efavirenz | Active Comparator |
| |
| C combination | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | multiple oral doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Cmax | Pre-dose and up to 24 hours post-dose on Days 14 and 28 | |
| Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Area under the concentration-time curve (AUC) | Pre-dose and up to 24 hours post-dose on Days 14 and 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| C553752 | danoprevir |
| C098320 | efavirenz |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| efavirenz |
| Drug |
multiple oral doses |
|
| ritonavir | Drug | multiple oral doses |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |