NCT00728052

A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers

A Placebo-controlled, Single-blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses (75mg and Above) of GSK598809 in Otherwise Healthy Smokers

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

Summary

Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence. It is important to evaluate how this drug interacts in healthy smokers. The study is planned to consist of a single part, with 4 dosing periods. Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at least 1 week of wash out between doses. In each dosing period 14 subjects will receive escalating doses and 4 subjects will receive placebo. The actual doses used will be determined based on the safety/ tolerability and pharmacokinetics during the previous dose. It is expected that the duration of this study will be approximately 10 weeks.

Conditions

• Substance Dependence

Interventions

Type	Name	Description
DRUG	GSK598809	GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.
DRUG	Placebo	Placebo capsules will be administered orally with water.

Timeline

• Start date: 2008-06-09
• Primary completion: 2008-08-19
• Completion: 2008-08-19
• First posted: 2008-08-05
• Last updated: 2017-08-03

Locations

1 site across 1 country: Germany