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The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.
Single dose escalation study of 5 dose levels of VBY-376. Eight subjects per group will receive one dose of VBY-376 then have multiple blood draws for pharmacokinetic evaluation and followed for safety with laboratory evaluations, ECG's, vital signs, and adverse events. Safety data will be reviewed before proceeding to the next dose.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VBY 376 | Drug | Doses of 50mg and higher or placebo will be evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of VBY-376 in single oral doses in healthy subjects. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen D Flach, MD | Covance CRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Sponsor website | View source |
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