Trial | NCT00557583  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vby-376 ...

  • Study Participants

    48
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.
Study Started
Nov 30
2007
Primary Completion
Feb 29
2008
Study Completion
Feb 29
2008
Last Update
Dec 31
2013
Estimate

Drug VBY 376

Doses of 50mg and higher or placebo will be evaluated.

Criteria 

Inclusion Criteria:

males and females between 18 and 45 years of age
screening body mass index between 20 and 29 kg/m2
in good health with no clinically significant medical conditions
able to comprehend and willing to sign an informed consent

Exclusion Criteria:

history of renal, hepatic impairment, stomach or intestinal surgery or resection, malabsorption syndrome
anemia or blood donation within 8 weeks of check-in
plasma donation within 4 weeks of check-in
history of alcoholism or drug addiction within 1 year prior to check-in
use of drugs of abuse
no tobacco-containing products within 6 months of study
participation of any clinical trial within 30 days
history or presence of abnormal ECG
no prescription or over-the-counter medications within 14 days of study and during the study
history of Gilbert's syndrome
No Results Posted