A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward
- Registration Number
- NCT00605241
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 29
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description GSK598809 GSK598809 Drug
- Primary Outcome Measures
Name Time Method Pharmacokinetics through 24 hours
- Secondary Outcome Measures
Name Time Method Stroop test through 10 hours
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Philadelphia, Pennsylvania, United States