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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006753-40 |
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This study will investigate the safety and tolerability of the first IV dosing of SLV338 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLV338 | Drug | 5 - 1000 mg IV |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability parameters, including administration site tolerability, adverse events, clinical laboratory tests, vital signs and ECG | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters: AUC, Cmax, tmax, t½, λz, CL, CLR, Vz, Vss, MRT, Ae, and fe. | 48 hours | |
| Pharmacodynamic parameters: Plasma levels of ANP, cGMP, BNP, VIP, Big ET, ET-1, angiotensin II and aldosteron. Urinary volume and urine levels of cGMP, sodium, potassium, chloride, uric acid and creatinine, and creatinine clearance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | London | United Kingdom |
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| Drug |
Placebo |
|
| 48 hours |