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- Title
Safety, bioavailability, and pharmacokinetics of VGX-1027-A novel oral anti-inflammatory drug in healthy human subjects.
- Authors
Lee, Jessica C.; Menacherry, Stanley; Diehl, Malissa C.; Giffear, Mary D.; White, C. Jo; Juba, Rob; Bagarazzi, Mark L.; Muthumani, Karuppiah; Boyer, Jean; Agarwal, Vipin; Nicoletti, Ferdinando; Bart, Stephen; Kim, J. Joseph; Weiner, David B.; Sardesai, Niranjan Y.
- Abstract
VGX-1027, a novel oral immune modulator, is under development for the treatment of rheumatoid arthritis. The safety, tolerability, and pharmacokinetics of single (1-800 mg) and multiple (40-400 mg) oral doses were evaluated in 2 clinical studies. The doses were well tolerated up to 800 mg in a single dose and 200 mg twice daily in multiple doses. Adverse events were mild to moderate in severity with no identifiable dose-related pattern. There were no clinically significant physical or laboratory findings. The pharmacokinetic data indicated that increases in Cmax and AUC0−inf were dose-proportional, and AUC0−τ was approximately dose-proportional. For the single-dose study, median Tmax ranged from 0.5 to 2 hours and mean t1/2 ranged from 4.9 to 8.7 hours. For the multiple-dose study, median Tmax ranged from 0.5 to 2.0 hours and mean t1/2 ranged from 7.05 to 10.05 hours. No accumulation of the drug was observed after day 1, indicating that steady-state concentrations were attained with single and multiple dosing for 5 days. Approximately 90% of the administered dose was excreted in urine as unchanged drug.
- Subjects
BIOAVAILABILITY; PHARMACOKINETICS; ANTI-inflammatory agents; IMMUNOREGULATION; RHEUMATOID arthritis treatment
- Publication
Clinical Pharmacology in Drug Development, 2016, Vol 5, Issue 2, p91
- ISSN
2160-763X
- Publication type
Article
- DOI
10.1002/cpdd.193