Trials / Completed
CompletedNCT00557583
Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults
A Randomized, Double-blinded, Placebo-controlled, Sequential, Single Ascending Dose Evaluation of the Safety and Pharmacokinetics of VBY-376 in Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Virobay Inc. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VBY 376 | Doses of 50mg and higher or placebo will be evaluated. |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2007-11-14
- Last updated
- 2013-12-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00557583. Inclusion in this directory is not an endorsement.