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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020314-29 |
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This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe hepatic impairment. Participants will be administered repeated daily doses of danoprevir and ritonavir. The anticipated time on study treatment is 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | Repeated oral doses |
| |
| ritonavir |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (plasma concentration) of danoprevir in patients with hepatic impairment | From baseline to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (incidence of adverse events) of danoprevir in patients with hepatic impairment | From baseline to day 10 |
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Inclusion Criteria:
Healthy Volunteers:
Patients with hepatic impairment:
Exclusion Criteria:
Healthy Volunteers:
Patients with hepatic impairment:
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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 |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Drug |
Repeated oral doses |
|
| Prague |
| 170 00 |
| Czechia |
| Prague | 180 00 | Czechia |
| Bratislava | 831 01 | Slovakia |
| Bratislava | 83305 | Slovakia |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |