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This is a multiple dose clinical study to be conducted with SRX246 capsules to determine the safety, tolerability and pharmacokinetics of the drug over a 14 day dosing period.
This study is intended to evaluate the safety, tolerability and pharmacokinetic profile of multiple oral doses of SRX246 in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRX246 | Experimental | SRX246 |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRX246 | Drug | capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be determined by performing vital sign measurements, ECGs, complete physical examinations, hematology and clinical chemistry tests, and recording of any reported adverse experiences. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of SRX246 will be determined by taking periodic blood samples for measurement of SRX246 levels. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan A Bart, MD | SNBL Clinical Pharmacology Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNBL Clinical Pharmacology Center | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| C584649 | SRX246 |
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