I agree wording changed from phase 2 to phase 1, but this is a pretty big phase 1 study, and is not just covering safety.
Further study details as provided by Shire:
Primary Outcome Measures:
Incidence of adverse events and clinically relevant changes in safety laboratory testing, vital signs, and 12-lead electrocardiograms [ Time Frame: 10 days (single-dose groups) or 17 days (multiple-dose groups) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Pharmacokinetic parameters (e.g., Cmax, Tmax, AUC, t1/2) [ Time Frame: 3 days (single-dose groups) or 10 days (multiple-dose groups) ] [ Designated as safety issue: No ]
Blood and urine samples will be collected to assess the pharmacokinetics of VP 20629 and a potential metabolite in plasma and urine after single and multiple doses of VP 20629.
Other Outcome Measures:
Pharmacodynamic parameters [ Time Frame: 10 days (multiple-dose groups only) ] [ Designated as safety issue: No ]
Blood and urine samples will be collected to measure biomarkers of oxidative stress and damage in the multiple-dose groups. These markers are plasma 8-isoprostane and malondialdehyde and urinary 8-hydroxydeoxyguanosine.
Estimated Enrollment: 56
Study Start Date: July 2013
Estimated Study Completion Date: November 2014
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