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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001019-38 | EudraCT Number |
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This two-part study will assess the safety and tolerability of single ascending oral doses of RO6806127 in a group of healthy male participants and investigate the effect of high fat and high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a separate group of healthy male participants. The relationship between drug exposure and tolerability will be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Adaptive model per protocol |
|
| Part 2: Food Effect (FE) | Experimental | Fasted versus Fed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo, administered orally with approximately 240 mL of buffer |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Phamacokinetic profile of single-dose oral RO6806127 and its metabolites as appropriate, as assessed by concentrations over time in plasma and urine | Up to Day 21 | |
| RO6806127 metabolite concentrations in selected plasma and urine samples | Up to Day 21 |
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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 |
|---|---|---|---|---|---|---|
| Marlton | New Jersey | 08053 | United States |
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| RO6806127 | Drug | Administered orally with approximately 240 mL of buffer |
|
| Relative bioavailability (food effect): Area under the concentration-time curves [AUC] | Up to Day 21 |