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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017008-10 | EudraCT Number |
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Part A completed successfully 22 July 2010, Part B will be separate PET study
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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance imaging (Part B)
The Part A of this study is a parallel design followed in a second part by a cross-over design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | Part A, Parallel design Arm 1 |
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| A2 | Experimental | Part A, Parallel design Arm 2 |
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| A3 | Experimental | Part A, Parallel design Arm 3 |
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| A4 | Experimental | Part A, Parallel design Arm 4 |
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| A5 | Experimental | Part A, Parallel design Arm 5 |
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| A6 | Experimental | Part A, Parallel design Arm 6 |
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| A7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLV354 capsules | Drug | 20 mg |
| |
| SLV354 capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part A) | 1 week after each dose level | |
| Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part B) | 2 weeks after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters (AUC and Cmax) after single ascending oral dosing of max. 8 doses of SLV354 ranging from 20 to 1250 mg (Part A) | 1 week after each dose level | |
| Pharmacodynamic variables (EEG, Cognitive tests, Questionnaires, plasma hormones ACTH / cortisol / TSH / T3 / T4) (Part A) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Beatrice Rendenbach-Mueller, PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 62002 | London | SE1 9RT | United Kingdom |
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| Experimental |
Part A, Parallel design Arm 7 |
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| A8 | Experimental | Part A, Parallel design Arm 8 |
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| A9 | Placebo Comparator | Part A, Parallel design Arm 9 |
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| B1-1 | Experimental | Part B, Cross-over design, Arm 1 |
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| B1-2 | Experimental | Part B, Cross-over design, Arm 2 |
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| B2-1 | Experimental | Part B, Cross-over design, Arm 3 |
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| B2-2 | Experimental | Part B, Cross-over design, Arm 4 |
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| B3 | Placebo Comparator | Part B, Cross-over design, Arm 5 |
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| Drug |
60 mg |
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| SLV354 capsules | Drug | 120 mg |
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| SLV354 capsules | Drug | 250 mg |
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| SLV354 capsules | Drug | 500 mg |
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| SLV354 capsules | Drug | 750 mg |
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| SLV354 capsules | Drug | 1000 mg |
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| SLV354 capsules | Drug | 1250 mg |
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| Placebo capsules | Drug | placebo |
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| SLV354 capsules | Drug | low dose group 1 |
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| SLV354 capsules | Drug | high dose group 1 |
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| SLV354 capsules | Drug | low dose group 2 |
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| SLV354 capsules | Drug | high dose group 2 |
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| Placebo capsules | Drug | placebo |
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| 1 week after each dose level |
| Pharmacokinetic parameters (AUC and Cmax) after single oral dosing of 2-4 doses of SLV354 chosen (Part B) | 2 weeks after each dose |
| Pharmacodynamic variables : Cognitive tests, Questionnaires, fMRI) (Part B) | 2 weeks after each dose |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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