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This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics of RO6870868 in healthy volunteers. Subjects will be randomized to receive single ascending doses of either RO6870868 or placebo, with or without food.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| RO6870868 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO6870868 | Drug | Single ascending doses |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | up to 44 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration-time curve (AUC) | Pre-dose and up to 48 hours post-dose | |
| Pharmacokinetics: Maximum plasma concentration (Cmax) | Pre-dose and up to 48 hours post-dose |
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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 |
|---|---|---|---|---|---|---|
| Zuidlaren | 9471 GP | Netherlands |
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| Drug |
Single ascending doses |
|
| Effect of food on pharmacokinetics: Area under the concentration-time curve (AUC) | Pre-dose and up to 48 hours post-dose |
| Pharmacodynamics: Cytokines/neopterin levels | Pre-dose and up to 48 hours post-dose |