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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002869-35 | EudraCT Number |
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This randomized, Investigator/Subject-blind, adaptive single-ascending-dose, placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics (including the effect of food), and pharmacodynamics of RO5545965 following oral administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2 doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period of approximately 2 weeks between treatment periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Placebo | Placebo Comparator |
| |
| Part 1: RO5545965 | Experimental |
| |
| Part 2: Food effect | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Single ascending dose |
| |
| RO5545965 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | up to approximately 10 weeks |
| 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 dose |
|
| RO5545965 | Drug | Single dose, in fed and fasted state |
|
| Pharmacodynamics: Prolactin levels | Pre-dose and up to 10 hours post-dose |
| Effect of food on the pharmacokinetics of single dose RO55459965: Area under the concentration-time curve (AUC) | pre-dose and up to 48 hours post-dose |