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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Substance Dependence

Treatments: Drug: Placebo; Drug: GSK598809

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437840

DAN107606

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

12 participants in 4 patient groups

Treatment Arm A

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: GSK598809

Treatment Arm B

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: GSK598809

Treatment Arm C

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: GSK598809

Treatment Arm D

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: GSK598809