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

Study Overview
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Brief Summary
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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.

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

Conditions
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Substance Dependence

Intervention / Treatment
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* Drug: GSK598809
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm A<br>In Arm A dosing subject will receive Placebo in Week 1, 10 milligram (mg) of GSK598809 in Week 2, 25 mg of GSK598809 in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. | Drug: GSK598809<br>* 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.<br>Drug: Placebo<br>* Subjects will receive single oral dose of matching placebo tablet to GSK598809.<br>|
| Experimental: Treatment Arm B<br>In Arm B dosing subject will receive 10 mg of GSK598809 in Week 1, Placebo in Week 2, 25 mg of GSK598809 in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. | Drug: GSK598809<br>* 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.<br>Drug: Placebo<br>* Subjects will receive single oral dose of matching placebo tablet to GSK598809.<br>|
| Experimental: Treatment Arm C<br>In Arm C dosing subject will receive 10 mg of GSK598809 in Week 1, 25 mg of GSK598809 in Week 2, Placebo in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. | Drug: GSK598809<br>* 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.<br>Drug: Placebo<br>* Subjects will receive single oral dose of matching placebo tablet to GSK598809.<br>|
| Experimental: Treatment Arm D<br>In Arm D dosing subject will receive 10 mg of GSK598809 in Week 1, 25 mg of GSK598809 in Week 2, 75 mg of GSK598809 in Week 3, Placebo in Week 4. Subjects will have a wash-out of period of one week before receiving another dose. | Drug: GSK598809<br>* 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.<br>Drug: Placebo<br>* Subjects will receive single oral dose of matching placebo tablet to GSK598809.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures: ECG, Vital Signs, Adverse Events |  | for 48 hours after dosing. | 
| PK: Blood levels of GSK598809 and nicotine |  | for 96 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaires on nicotine craving |  | for 24 hours after dosing | 
| Tests on cognition (thinking) |  | for 48 hours after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers,, tolerability,, pharmacokinetics,, pharmacodynamics, safety,, smoking,