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- To determine the excretion balance and systemic exposure of radioactivity after intravenous infusion of [14C]-AVE8062 to humans
- To determine the pharmacokinetics of AVE8062 and RPR258063 and their contribution to overall exposure
- To collect samples to determine the metabolic pathways of AVE8062 and identify the chemical structures of the main metabolites
- To assess the safety profile of the drug
The duration of the study for each patient will include approximately 4 weeks of a screening phase prior to first infusion of study drug, 21-day study treatment cycles and end of treatment visit. The patient can continue treatment until disease progression, unacceptable toxicity, or the patient's refusal of further treatment.
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Sanofi-Aventis Administrative Office
Published on BioPortfolio: 2014-07-24T14:10:04-0400
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