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This non-randomized, open-label study will evaluate the interaction of RO5190591(danoprevir)/ritonavir with and without ketoconazole and the safety and tolerability in healthy volunteers. Participants will be administered repeated daily doses of ketoconazole alone, RO5190591/ritonavir, and RO5190591/ritonavir plus ketoconazole. The anticipated time on study treatment is 25 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | Repeated daily doses |
| |
| ketoconazole |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the interaction between RO5190591/ritonavir and ketoconazole | Day 40 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole | Day 40 |
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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 |
| D007654 | Ketoconazole |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
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| Drug |
Repeated daily doses |
|
| ritonavir | Drug | Repeated daily doses |
|
| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |