Replies to post #19965 on Intellect Neurosciences Inc. (fka ILNS)

[Jumpinjackas]

They are talking about the first one, there was a phase I before the phase Ib.

[montanus]

About Disorders Caused by Oxidative Stress

http://www.oxidativestressresource.org/


SHP622 - trial outcome:

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.

https://clinicaltrials.gov/ct2/show/NCT01898884?term=viropharma&rank=6