Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults
The study will evaluate the safety and pharmacokinetics of single doses of VBY-376 in healthy subjects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
|Official Title:||A Randomized, Double-blinded, Placebo-controlled, Sequential, Single Ascending Dose Evaluation of the Safety and Pharmacokinetics of VBY-376 in Healthy Adults|
- To evaluate the safety of VBY-376 in single oral doses in healthy subjects. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- To evaluate the pharmacokinetics of VBY-376 after single oral doses and the effect of food on VBY-376. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Drug: VBY 376
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.