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OpenTrials
Completed

NCT Number: NCT00437840

A Study To Investigate The Safety, Tolerability And Blood Levels Of GSK598809

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.

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Key information

Conditions

Substance Dependence Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Berlin, 13251, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK598809

Drug

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.

Placebo

Drug

Subjects will receive single oral dose of matching placebo tablet to GSK598809.

Primary outcomes

  1. Safety measures: ECG, Vital Signs, Adverse Events

    Time frame: for 48 hours after dosing.

  2. PK: Blood levels of GSK598809 and nicotine

    Time frame: for 96 hours after dosing

Secondary outcomes

  1. Questionnaires on nicotine craving

    Time frame: for 24 hours after dosing

  2. Tests on cognition (thinking)

    Time frame: for 48 hours after dosing

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Placebo-controlled, Single-blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses of GSK598809 in Smokers

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 21, 2007
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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