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

August 3, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13251
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Drug: Placebo
Subjects will receive single oral dose of matching placebo tablet to GSK598809.
Experimental: 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.
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.
Drug: Placebo
Subjects will receive single oral dose of matching placebo tablet to GSK598809.
Experimental: 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.
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.
Drug: Placebo
Subjects will receive single oral dose of matching placebo tablet to GSK598809.
Experimental: 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.
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.
Drug: Placebo
Subjects will receive single oral dose of matching placebo tablet to GSK598809.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety measures: ECG, Vital Signs, Adverse Events
Time Frame: for 48 hours after dosing.
for 48 hours after dosing.
PK: Blood levels of GSK598809 and nicotine
Time Frame: for 96 hours after dosing
for 96 hours after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Tests on cognition (thinking)
Time Frame: for 48 hours after dosing
for 48 hours after dosing
Questionnaires on nicotine craving
Time Frame: for 24 hours after dosing
for 24 hours after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2007

Primary Completion (Actual)

June 20, 2007

Study Completion (Actual)

June 20, 2007

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAN107606

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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