The broad objective of the proposed clinical investigation is to establish that oral administration of the hypoxia marker, pimonidazole HCl is as safe and effective as intravenous administration. The goal is to improve patient comfort and convenience and minimize the invasiveness of the Hypoxyprobe technique in preparation for commercialization for clinical use. The clinical study has been conducted with Institutional Review Board approval at the University of North Carolina at Chapel Hill (UNC). Other centers with local Principal Investigators who have cross-referenced this IND conduct independent studies with approval of their respective IRBs.
The drug substance pimonidazole HCl (1-[(2-hydroxy-3-piperidinyl)propyl]-2-nitroimidazole HCl), also known as Hypoxyprobe™-1 and Ro-03-8799 (Hoffman LaRoche), is a 2-nitroimidazole compound substituted at the 3-position of the side chain with a weakly basic, piperidine substituent in the form of its hydrochloride salt.
Oral Pimonidazole HCl - 300 mg Capsules