Substance Dependence
Conditions
Keywords
healthy volunteers,, tolerability,, pharmacokinetics,, pharmacodynamics, safety,, smoking,
Brief summary
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.
Interventions
DRUGGSK598809
GSK598809 capsules will be available in dose strength of 5 and 25 mg. Subjects will receive single oral dose of GSK598809 n order to achieve the required dose.
DRUGPlacebo
Subjects will receive single oral dose of matching placebo tablet to GSK598809.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measures: ECG, Vital Signs, Adverse Events | for 48 hours after dosing. |
| PK: Blood levels of GSK598809 and nicotine | for 96 hours after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaires on nicotine craving | for 24 hours after dosing |
| Tests on cognition (thinking) | for 48 hours after dosing |
Countries
Germany
Outcome results
None listed