NCT00437632

Study To Investigate If Repeat Doses Of GSK598809 Are Safe And Well Tolerated And To Evaluate Blood Levels Of GSK598809

A Placebo Controlled, Single Blind, Randomised Study Investigating the Safety, Tolerability and Pharmacokinetics of Repeated Oral Doses of GSK598809 in Healthy Male and Female Volunteers for 28 Days.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will evaluate the safety, tolerability and pharmacokinetics of repeat doses of GSK598809 in healthy volunteers.

Conditions

• Substance Dependence

Interventions

Type	Name	Description
DRUG	GSK598809	GSK598809 will be available as 5 and 25 mg capsules. Subjects will receive GSK598809 capsules orally with water.
DRUG	Placebo	Subjects will receive matching placebo capsules to GSK598809 orally with water.
DRUG	Caffeine	Caffeine 100 mg will be available as oral solution or tablet and subjects will receive Caffeine 100 mg orally on -1 day. On Day 35 caffeine and GSK598809 will be co-administered.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-08-22
• Completion: 2008-08-22
• First posted: 2007-02-21
• Last updated: 2017-07-31

Locations

1 site across 1 country: United Kingdom