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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023641-30 | EudraCT Number |
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This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral dose of RO4917838.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects | Experimental |
| |
| Hepatic impairment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4917838 | Drug | single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax) | 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 29 days |
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Inclusion Criteria:
General:
Healthy Subjects:
Hepatically impaired patients:
Exclusion Criteria:
General:
Healthy volunteers:
Hepatically impaired patients:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes | 35042 | France | ||||
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| Moscow |
| 117192 |
| Russia |
| Moscow | 117292 | Russia |