Safety and Pharmacology Study of VP 20629 (now called SHP622) in Adults With FA
Ages: 18-45
Locations: Children's Hospital of Philadephia (CHOP), Emory, University of South Florida, University of Iowa, UCLA
Details: This is a Phase 1 study sponsored by Shire (formerly initiated by ViroPharma) designed to evaluate dosage and safety of VP20629, a naturally occurring small molecular weight drug compound that can prevent oxidative stress to improve mitochondrial function. Participation in this study requires both outpatient and inpatient visits. Subjects in the second arm need to stay in the hospital for 10 days. In the second arm, subjects will receive multiple doses of VP 20629 (300 mg, 600 mg, or 900 mg total daily dose) or placebo. VP20629 or placebo will be administered every 8 hours for 7 days with a single morning dose on Day 8.
