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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00437840
First received: February 20, 2007
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Smoking
Healthy Subjects
Drug: GSK598809
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • Questionnaires on nicotine craving [ Time Frame: for 24 hours after dosing ]
  • Tests on cognition (thinking) [ Time Frame: for 48 hours after dosing ]

Enrollment: 12
Study Start Date: March 2007
Intervention Details:
    Drug: GSK598809
    Other Name: GSK598809
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437840

Locations
Germany
GSK Investigational Site
Berlin, Germany, 13251
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, M.D. GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00437840     History of Changes
Other Study ID Numbers: DAN107606
Study First Received: February 20, 2007
Last Updated: October 9, 2008
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
smoking,
healthy volunteers,
safety,
tolerability,
pharmacokinetics,
pharmacodynamics

ClinicalTrials.gov processed this record on September 30, 2014