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

Completed · Phase 1

Conditions studied: Substance Dependence

In brief

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.

Key facts

Study ID

NCT00605241

Run by

GlaxoSmithKline

People needed

29

Starts

2008-02-25

Expected to finish

2009-03-20

Last updated by the study team

2017-07-21

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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