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

Primary Purpose

Substance Dependence

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
GSK598809
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Dependence focused on measuring healthy volunteers,, tolerability,, pharmacokinetics,, pharmacodynamics, safety,, smoking,

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts 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.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment Arm A

Treatment Arm B

Treatment Arm C

Treatment Arm D

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Safety measures: ECG, Vital Signs, Adverse Events
PK: Blood levels of GSK598809 and nicotine

Secondary Outcome Measures

Questionnaires on nicotine craving
Tests on cognition (thinking)

Full Information

First Posted
February 20, 2007
Last Updated
August 3, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00437840
Brief Title
A Study To Investigate The Safety, Tolerability And Blood Levels Of GSK598809
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 20, 2007 (Actual)
Primary Completion Date
June 20, 2007 (Actual)
Study Completion Date
June 20, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependence
Keywords
healthy volunteers,, tolerability,, pharmacokinetics,, pharmacodynamics, safety,, smoking,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm A
Arm Type
Experimental
Arm 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.
Arm Title
Treatment Arm B
Arm Type
Experimental
Arm 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.
Arm Title
Treatment Arm C
Arm Type
Experimental
Arm 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.
Arm Title
Treatment Arm D
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
GSK598809
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive single oral dose of matching placebo tablet to GSK598809.
Primary Outcome Measure Information:
Title
Safety measures: ECG, Vital Signs, Adverse Events
Time Frame
for 48 hours after dosing.
Title
PK: Blood levels of GSK598809 and nicotine
Time Frame
for 96 hours after dosing
Secondary Outcome Measure Information:
Title
Questionnaires on nicotine craving
Time Frame
for 24 hours after dosing
Title
Tests on cognition (thinking)
Time Frame
for 48 hours after dosing

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13251
Country
Germany

12. IPD Sharing Statement

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

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