Status:
COMPLETED
A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Substance Dependence
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicoti...
Eligibility Criteria
Inclusion
- Inclusion:
- A healthy man or woman
- 18 - 50 years old
- Neither too fat, nor too thin
- Female subjects must use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up visit.
- Female subjects must not be breast feeding and should not have been breast feeding for a month.
- Male subjects must agree to use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up.
- Subjects need to smoke 20 - 40 cigarettes a day inclusive for at least the past year and to not have tried to quit in the 3 months before the start of the study.
- Exclusion:
- Any current medical or psychiatric illness
- Any history of chronic medical or psychiatric illnesses
- Previous or current alcohol or drug abuse/dependence including nicotine
- Personal or family history of prolonged QTc syndrome
Exclusion
Key Trial Info
Start Date :
June 9 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00728052
Start Date
June 9 2008
End Date
August 19 2008
Last Update
August 3 2017
Active Locations (1)
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1
GSK Investigational Site
Berlin, Germany, 13251