Substance Dependence
Conditions
Keywords
pharmacodynamics,, pharmacokinetics,, tolerability,, Safety,, single dose,, placebo,, Nicotine reward, GSK598809
Brief summary
GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will asses the effects of a single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of at least seven days between each session.
Interventions
DRUGGSK598809
Drug
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male smokers aged 18-65 with a desire to quit smoking. * Body weight greater than 50kg and BMI within range 19 - 29.9 kg/m2 * Healthy with no significant medical, psychiatric or laboratory evaluation abnormality.
Exclusion criteria
* Positive pre-study urine drug/breath alcohol screen: positive HIV 1/2, Hepatitis B or Hepatitis C test at screening. * History of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study. * History of psychiatric disorder or sensitivity to any of the study medications or components thereof or a history of drug or allergy that in the opinion of the physician responsible contraindicates their participation. * History of cardiac or pulmonary disease/abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | through 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Stroop test | through 10 hours |
Countries
United States
Outcome results
None listed