Phytopharm's Cogane enters Ph I PK study

UK drug developer Phytopharm has commenced a safety, tolerability and pharmacokinetic study of its orally-active neurotrophic factor inducer  Cogane (PYM50028), which will involve both healthy volunteers and  patients with Parkinson's disease.

To be conducted on a part residential, part out-patient basis, the study  will employ a randomized, double-blind, multiple dose-ascending,  placebo-controlled design to evaluate the safety, tolerability and PK  profile of a new, oral solution formulation of Cogane when taken for up  to 28 days at various dose levels. In total, 18 healthy male and female  volunteers and up to the same number with PD aged between 40-80 years,  are planned to be enrolled with doses being escalated sequentially  following a safety review at each dose level.

The primary objective of this study is to confirm the safety and  tolerability of the agent in healthy subjects and PD patients when  administered at these dose levels for up to 28 days, the secondary  objective being to determine its plasma PK profile.