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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005773-31 | EudraCT Number |
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This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at least 7 days between dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: RO6811135 s.c. | Experimental |
| |
| B: RO6811135 i.v. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO6811135 | Drug | Single subcutaneous dose |
| |
| RO6811135 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 5 weeks | |
| Pharmacodynamics: Fasting serum glucose/serum insulin | 48 hours | |
| Nausea scale: Visual analogue scale |
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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 |
|---|---|---|---|---|---|---|
| Leeds | LS2 9LH | United Kingdom |
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| Drug |
Single intravenous dose |
|
| 48 hours |