NCT01059578

First Study in Humans With GSK206136

A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK206136 in Healthy Male Subjects and an Open Label Positron Emission Tomography Study to Evaluate the Serotonin Transporter and Neurokinin-1 Receptor Occupancy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is the first study in humans with GSK206136 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	GSK206136	GSK206136 2mg, 10mg, 50mg, 100mg capsule
DRUG	PLACEBO	Placebo to match 206136 2mg, 10mg, 50mg, 100mg capsule
RADIATION	PET	Each subject will undergo 3 PET Scans ; one at Baseline and the others following dosing with GSK206136 at approximately 2 hours post-dose and 24 hours post-dose

Timeline

• Start date: 2006-05-23
• Primary completion: 2006-12-18
• Completion: 2006-12-18
• First posted: 2010-02-01
• Last updated: 2017-08-10

Locations

1 site across 1 country: United Kingdom