NCT00437840

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
27 days until next milestone

Study Start

First participant enrolled

March 20, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2007

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

February 20, 2007

Last Update Submit

August 3, 2017

Conditions

Substance Dependence

Keywords

healthy volunteers,tolerability,pharmacokinetics,pharmacodynamicssafety,smoking,

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Questionnaires on nicotine craving

    for 24 hours after dosing

  • Tests on cognition (thinking)

    for 48 hours after dosing

Study Arms (4)

Treatment Arm A

EXPERIMENTAL

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: GSK598809Drug: Placebo

Treatment Arm B

EXPERIMENTAL

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: GSK598809Drug: Placebo

Treatment Arm C

EXPERIMENTAL

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: GSK598809Drug: Placebo

Treatment Arm D

EXPERIMENTAL

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: GSK598809Drug: Placebo

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.

Treatment Arm ATreatment Arm BTreatment Arm CTreatment Arm D
PlaceboDRUG

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

Treatment Arm ATreatment Arm BTreatment Arm CTreatment Arm D

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • History of psychiatric disorder or sleep disorder.
  • Receiving treatment for smoking cessation.
  • Use tobacco products other than cigarettes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Berlin, 13251, Germany

Location

Related Links

MeSH Terms

Conditions

Substance-Related DisordersSmoking

Interventions

GSK598809

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 21, 2007

Study Start

March 20, 2007

Primary Completion

June 20, 2007

Study Completion

June 20, 2007

Last Updated

August 7, 2017

Record last verified: 2017-08

Locations

DE(1)