A Study To Investigate The Safety, Tolerability And Blood Levels Of GSK598809 - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00437840

Purpose

GSK598809 is being developed to facilitate overcoming an addiction to nicotine and to help people stop smoking. This study will investigate if GSK598809 is safe and tolerated in people who smoke and will also look at blood levels of GSK598809 and nicotine.

Condition	Intervention	Phase
Smoking Healthy Subjects	Drug: GSK598809	Phase I

MedlinePlus related topics: Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Single Group Assignment, Safety Study
Official Title:	A Placebo-Controlled, Single-Blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses of GSK598809 in Smokers

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Safety measures: ECG, Vital Signs, Adverse Events [ Time Frame: for 48 hours after dosing. ]
PK: Blood levels of GSK598809 and nicotine [ Time Frame: for 96 hours after dosing ]

Secondary Outcome Measures:

Questionnaires on nicotine craving [ Time Frame: for 24 hours after dosing ]
Tests on cognition (thinking) [ Time Frame: for 48 hours after dosing ]

Enrollment:	12
Study Start Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Healthy adult male smoker between the ages of 18 and 50 years
Body weight greater than 50kg and BMI between 18.5-29.9 kg/m2.
No abnormalities on the medical, psychiatric or laboratory evaluation
Smoke on average more than 20 but less that 40 cigarettes per day for the past year and not tried to give up in the 3 months before the study.

Exclusion criteria:

History of psychiatric disorder or sleep disorder.
Receiving treatment for smoking cessation.
Use tobacco products other than cigarettes.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437840

Locations

Germany
GSK Investigational Site
Berlin, Germany, 13251

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, M.D.

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	DAN107606
Study First Received:	February 20, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00437840
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

smoking,
healthy volunteers,
safety,

tolerability,
pharmacokinetics,
pharmacodynamics

Study placed in the following topic categories:

Smoking
Healthy

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 15, 2009