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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437840
First Posted: February 21, 2007
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Substance Dependence Drug: GSK598809 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
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

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
Actual Study Start Date: March 20, 2007
Study Completion Date: June 20, 2007
Primary Completion Date: June 20, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437840


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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00437840     History of Changes
Other Study ID Numbers: DAN107606
First Submitted: February 20, 2007
First Posted: February 21, 2007
Last Update Posted: August 7, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders