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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-20

Study Completion Date

2007-06-20

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.

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Detailed Description

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Conditions

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Substance Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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Treatment Arm A

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.

Group Type EXPERIMENTAL

GSK598809

Intervention Type 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

Intervention Type DRUG

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

Treatment Arm B

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.

Group Type EXPERIMENTAL

GSK598809

Intervention Type 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

Intervention Type DRUG

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

Treatment Arm C

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.

Group Type EXPERIMENTAL

GSK598809

Intervention Type 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

Intervention Type DRUG

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

Treatment Arm D

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.

Group Type EXPERIMENTAL

GSK598809

Intervention Type 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

Intervention Type DRUG

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

Interventions

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GSK598809

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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

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.