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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000718-78 | EudraCT Number |
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This study is designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO6799477 following once daily oral administration for 2 weeks in healthy volunteers (Part 1) and in Type 2 diabetes patients (T2D) (Part 2). The anticipated time on study treatment is two weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Healthy Volunteers | Experimental |
| |
| Part 2: Patients with T2D, Group A | Experimental | Low dose daily oral administration of RO6799477 |
|
| Part 2: Patients with T2D, Group B | Experimental | High dose daily oral administration of RO6799477 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo daily oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters derived from plasma and urine concentrations of RO6799477, area under the concentration time curve (AUC), Cmax | Day 1 and Day 14 | |
| Fasting serum glucose | Up to 9 weeks | |
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Inclusion Criteria:
Part 1 Inclusion criteria:
Part 2 Inclusion Criteria:
Exclusion Criteria:
Part 1 Exclusion criteria:
Part 2 Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden | 2333 | Netherlands |
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| RO6799477 | Drug | Daily oral administration of RO6799477 |
|
| Fasting serum insulin (Part 2 only) |
| Up to 9 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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