A Study To Investigate The Safety, Tolerability And Blood Levels Of GSK598809
This study has been completed.
Information provided by:
First received: February 20, 2007
Last updated: October 9, 2008
Last verified: October 2008
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.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
||A Placebo-Controlled, Single-Blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses of GSK598809 in Smokers
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 ]
| Study Start Date:
Other Name: GSK598809
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- History of psychiatric disorder or sleep disorder.
- Receiving treatment for smoking cessation.
- Use tobacco products other than cigarettes.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437840
|GSK Investigational Site
|Berlin, Germany, 13251 |
||GSK Clinical Trials, M.D.
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 20, 2007
||October 9, 2008
||United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by GlaxoSmithKline:
ClinicalTrials.gov processed this record on November 24, 2014