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This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be randomized to receive either RO5545965 or matching placebo daily for 12 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| RO5545965 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5545965 | Drug | Multiple ascending doses |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration-time curve (AUC) | 17 days | |
| Pharmacokinetics: Plasma concentrations | 17 days | |
| Pharmacokinetics: Urine concentrations |
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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 |
Multiple ascending doses |
|
| 13 days |
| Pharmacodynamics: Serum prolactin levels | Day 12 |
| Pharmacodynamics: Glucose tolerance test | Day 11 |
| Pharmacodynamics: Probabilistic learning tasks | Days 6, 8 and 10 |