Overview

Safety and Pharmacology Study of VP 20629 in Adults With Friedreich's Ataxia

Status:
Completed
Trial end date:
2015-06-18
Target enrollment:
Participant gender:
Summary
The objectives of the study are: - To evaluate the safety and tolerability of single and multiple oral doses of VP 20629 in subjects with Friedreich's ataxia (FA). [Primary] - To characterize the pharmacokinetics of VP 20629 by investigation of the plasma concentration-time profile following single and multiple oral doses in subjects with FA. [Secondary] - To investigate the pharmacodynamic effects of VP 20629 on plasma 8-isoprostane and malondialdehyde and urinary 8-hydroxydeoxyguanosine concentrations following multiple oral doses in subjects with FA. [Exploratory]
Phase:
Phase 1
Details
Lead Sponsor:
Shire