A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Substance Dependence

Treatments

Drug: GSK598809

Study type

Interventional

Funder types

Industry

Identifiers

NCT00605241

DAN106593

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.