NCT01634529

Single and Multiple Ascending Dose Study of V158866 in Healthy Volunteers

A Double-blind, Randomised, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of V158866 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Vernalis (R&D) Ltd · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate whether V158866 is safe when given to healthy male subjects in single and multiple doses.

Detailed description

A first in human study: To evaluate the safety and tolerability of single and multiple doses of V158866 in healthy male subjects To assess the pharmacokinetics (PK) of V158866 in healthy male subjects To assess the pharmacodynamics (PD) of V158866 by determining whether V158866 inhibits fatty acid amide hydrolase (FAAH ) in healthy male subjects

Conditions

• First in Man Study

Interventions

Type	Name	Description
DRUG	V158866	Single ascending oral doses of V158866 and Placebo
DRUG	V158866	Multiple ascending oral doses of V158866 and Placebo

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2012-07-06
• Last updated: 2012-07-11

Locations

1 site across 1 country: United Kingdom