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This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects Arm | Experimental |
| |
| Renal Impaired Subjects Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4917838 | Drug | Single dose of RO4917838 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under concentration time curve of RO4917838 | Days 1-16 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 9 weeks |
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Inclusion Criteria:
General criteria
Criteria applying to renal impaired subjects
Criteria applying to healthy subjects
Exclusion Criteria:
General criteria
Criteria applying to renal impaired subjects
Criteria applying to healthy subjects
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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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| RO4917838 |
| Drug |
Single dose of RO4917838 |
|
| Moscow |
| 117192 |
| Russia |
| Moscow | 117292 | Russia |