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

GlaxoSmithKline12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Substance Dependence

Interventions

GSK598809DRUG

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.

PlaceboDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Berlin, Germany

Outcomes

Primary Outcomes

Safety measures: ECG, Vital Signs, Adverse Events

Time frame: for 48 hours after dosing.

PK: Blood levels of GSK598809 and nicotine

Time frame: for 96 hours after dosing

Secondary Outcomes

Questionnaires on nicotine craving

Time frame: for 24 hours after dosing

Tests on cognition (thinking)

Time frame: for 48 hours after dosing

Data from ClinicalTrials.gov

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