NCT01059591

First Study in Humans With GSK424887

A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK424887 in Healthy Male Subjects and an Open Label Positron Emission Tomography Study to Evaluate the Serotonin Transporter and Neurokinin- Receceptor Occupancy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is the first study in Humans with GSK424887 to evaluate what effects, good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to investigate the penetration of the drug in the human brain by using PET (Positron Emission Tomography) imaging technology

Conditions

• Depressive Disorder and Anxiety Disorders

Interventions

Type	Name	Description
DRUG	GSK424887	GSK424887 2mg, 10mg, 50mg, 100mg capsule
DRUG	Placebo	Placebo to match GSK424887 2mg, 10mg,50mg, 100mg capsule
RADIATION	PET	Each subject will undergo 3 PET scans : one at Baseline and the others following dosing with GSK424887 at approximately 2h post-dose and aproximately 24 hours post-dose

Timeline

• Start date: 2006-05-25
• Primary completion: 2007-01-25
• Completion: 2007-01-25
• First posted: 2010-02-01
• Last updated: 2017-08-11

Locations

1 site across 1 country: United Kingdom