Last updated: 11/04/2018 06:08:58

A human volunteer study investigating single oral doses of GSK598809 in otherwise healthy smokers

GSK study ID
DAN111282
See study documents
Clinicaltrials.gov ID
NCT00728052
EudraCT ID
2008-001166-82
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 (75mg and above) of GSK598809 in otherwise healthy smokers
Trial description: 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 nicotine dependence. It is important to evaluate how this drug interacts in healthy smokers. The study is planned to consist of a single part, with 4 dosing periods. Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at least 1 week of wash out between doses. In each dosing period 14 subjects will receive escalating doses and 4 subjects will receive placebo. The actual doses used will be determined based on the safety/ tolerability and pharmacokinetics during the previous dose. It is expected that the duration of this study will be approximately 10 weeks.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Safety and tolerability: Clinical labs, cardiovascular variables, vital signs, adverse events over 48 hours post dosing and at follow up. Psychological assessment and movement scales will be monitored. Blood Sampling over 48 hours.

Timeframe: 48 hours post dose

Secondary outcomes:

Cigarette craving assessed over 24 hours around dosing. Cigarette Consumption to be monitored during the whole study.Withdrawal from nicotine assessed during first four hours of dosing. Cognition/ impulsivity assessed over 24 hours after dosing.

Timeframe: 24 hours

Interventions:
Drug: GSK598809
Drug: Placebo
Enrollment:
18
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)
June 2008 to August 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
  • Inclusion:
  • A healthy man or woman
Inclusion and exclusion criteria
Inclusion criteria:

    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

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
2008-19-08

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 DAN111282 can be found on the GSK Clinical Study Register.
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