TorreyPines initiates Ph I trial of NGX267

USA-based TorreyPines Therapeutics has initiated a Phase I multiple-dose clinical trial to evaluate the safety, tolerability and pharmacokinetics of NGX267 when given once-daily for four days to healthy male volunteers. The agent, a potential treatment for cognitive impairment associated with schizophrenia (CIAS), is a functionally-selective muscarinic (M1) receptor agonist. In a previous Phase I trial, the agent was well-tolerated at single doses believed to be effective for treating memory and cognitive disturbances.

This double-blind, placebo-controlled, multiple-dose trial will enroll 90 healthy males, between the ages of 18 and 55, in sequential cohorts at one center in Belgium. Doses of 10mg, 20mg, 30mg and 35mg will be evaluated. The highest planned dose represents the maximum tolerated single dose of NGX267 from an earlier Phase I study. In that previous trial, evidence of cholinergic stimulation, as measured by increase in salivary flow, was detected and there were no clinically notable adverse events. Evaluation of drug-related increases in salivary flow is included in this study as a secondary objective, the firm noted.