Date: 2012-08-13
Type of information:
phase: 1
Announcement: presentation of results at the 14th Annual World Congress on Pain Meeting (Milan, 27th to 31st August 2012)
Company: Vernalis (UK)
Product: V158866 (fatty acid amide hydrolase (FAAH) inhibitor)
Action mechanism:
Disease: pain
Therapeutic area: CNS diseases
Country:
Trial details: The double-blind, placebo controlled study investigated single and multiple ascending doses and was conducted in healthy male volunteers.
Latest
news: Vernalis has announced results from its Phase I trial of V158866, its fatty acid amide hydrolase (FAAH) inhibitor will be presented at the 14th Annual World Congress on Pain Meeting, which is being held in Milan from 27th to 31st August 2012. Interim result of the double-blind, placebo controlled study were published in September 2011. The Phase I study investigating single and multiple ascending doses was conducted in healthy male volunteers. Both single dose and repeated administration for 7 days across a wide range of doses were found to be well tolerated with no safety concerns identified. There were few adverse events at any dose, including the highest dose studied, 500 mg once daily for 7 days. The pharmacokinetics of the compound were found to be straightforward, with good exposures that increased in an approximately linear fashion with oral dosing. There were clear changes in the pharmacodynamic markers (plasma FAAH activity and endocannabinoid concentrations) at all doses studied, including even the lowest single dose (5 mg).
