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This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983 or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks for the SAD part and up to 8 weeks for the MAD part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo - MAD | Drug | Once or twice daily doses of matching placebo to RO5271983 for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983 | up to 240 hours | |
| Single ascending dose (SAD): Safety (incidence of adverse events) | 14 weeks | |
| Single ascending dose (SAD): Tolerability (e.g. vital signs) | 14 weeks | |
| Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983 | 17 days | |
| Multiple ascending doses (MAD): Safety (incidence of adverse events) | 8 weeks | |
| Multiple ascending doses (MAD): Tolerability (e.g. vital signs) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of food on pharmacokinetics of RO5271983 | up to 240 hours | |
| Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983 | 72 hours | |
| Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983 |
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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 |
|---|---|---|---|---|---|---|
| Christchurch | 8011 | New Zealand |
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| Placebo - SAD |
| Drug |
Single dose of matching placebo to RO5271983 for up to 3 periods |
|
| RO5271983 - MAD | Drug | Once or twice daily doses of RO5271983 for 14 days |
|
| RO5271983 - SAD | Drug | Single dose of RO5271983 at each period (for up to 3 periods) |
|
| 14 days |