Study FP003SE: Evaluation of the Acute Toxicity, Gene Expression, Protein Expression, Metabolite Production, Clinical Chemistry and Pathology Profile Following an Oral Administration of Compound AS605134 to Rats

Repeated dose 14-day toxicity study in adult male rats (Rattus norvegicus), Wistar strain, using chemical compound FP003SE, administered daily orally, sponsored by Serono, funded by European Union Framework Program 6 - Innovative Medicines Initiatives - Integrated Project Predictive Toxicology (EU FP6 InnoMed PredTox: LSHB-CT-2005-518170), The study will examine the gene, protein and metabolite profiles, along with traditional toxicological endpoint information in the liver, kidney, blood and urine of rats 1-14 days after exposure. By design, low doses lie between No Observed Adverse Effect Level (NOAEL) and Lowest Observed Adverse Effect Level (LOAEL).