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

Substance Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437840
• Other study ID #: DAN107606
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2007
• Last updated: August 3, 2017
• Start date: March 20, 2007
• Est. completion date: June 20, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 20, 2007
• Est. primary completion date: June 20, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Dependence
• Substance-Related Disorders

Intervention

Drug:
• 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.
• Placebo
Subjects will receive single oral dose of matching placebo tablet to GSK598809.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measures: ECG, Vital Signs, Adverse Events		for 48 hours after dosing.
Primary	PK: Blood levels of GSK598809 and nicotine		for 96 hours after dosing
Secondary	Questionnaires on nicotine craving		for 24 hours after dosing
Secondary	Tests on cognition (thinking)		for 48 hours after dosing

External Links

•   Results for study DAN107606 can be found on the GSK Clinical Study Register.