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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000600-17 | EudraCT Number |
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This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5267683 | Drug | Multiple ascending doses |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Plasma concentrations | 14 weeks | |
| Pharmacokinetics: Urine concentrations | 4 weeks | |
| Lipid levels in the blood |
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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 |
|---|---|---|---|---|---|---|
| Strasbourg | 67064 | France |
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| Drug |
Multiple ascending doses |
|
| 14 weeks |