Last updated: 11/04/2018 06:08:51

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

GSK study ID
DAN107606
See study documents
Clinicaltrials.gov ID
NCT00437840
EudraCT ID
2006-005430-20
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Safety measures: ECG, Vital Signs, Adverse Events

Timeframe: for 48 hours after dosing.

PK: Blood levels of GSK598809 and nicotine

Timeframe: for 96 hours after dosing

Secondary outcomes:

Questionnaires on nicotine craving

Timeframe: for 24 hours after dosing

Tests on cognition (thinking)

Timeframe: for 48 hours after dosing

Interventions:
Drug: GSK598809
Drug: Placebo
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Substance Dependence
Product
GSK598809
Collaborators
Not applicable
Study date(s)
March 2007 to June 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
  • 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.
  • History of psychiatric disorder or sleep disorder.
  • Receiving treatment for smoking cessation.
Inclusion and exclusion 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Berlin, Berlin, Germany, 13251
Status
Study Complete
Contact us

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-20-06

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study DAN107606 can be found on the GSK Clinical Study Register.
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Access to clinical trial data by researchers
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