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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014245-88 | EudraCT Number |
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Terminated on 14 Sep 2010 due to strategic considerations
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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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First in man study with single and multiple rising doses with SLV342
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | SLV342 suspension or capsule |
|
| B | Placebo Comparator | matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLV342 | Drug | 25 mg once daily - Maximal Tolerated Dose |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR | 28 days | |
| Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring | 28 days | |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid Meuwsen, MS | Abbott Healthcare Products B.V | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 61142 | London | SE1 1YR | United Kingdom |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Drug |
matching placebo |
|
| Midazolam PK parameters |
| 24 hours |