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A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00728052
First Posted: August 5, 2008
Last Update Posted: August 3, 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
August 1, 2008
August 5, 2008
August 3, 2017
June 9, 2008
August 19, 2008   (Final data collection date for primary outcome measure)
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. [ Time Frame: 48 hours post dose ]
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.
Complete list of historical versions of study NCT00728052 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 24 hours ]
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.
Not Provided
Not Provided
 
A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Substance Dependence
  • Drug: GSK598809
    GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.
  • Drug: Placebo
    Placebo capsules will be administered orally with water.
  • Experimental: Subjects receiving treatment sequence ABCD
    Subjects will receive treatment sequence ABCD; A= placebo, B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, and D = GSK598809 dose 3.
    Interventions:
    • Drug: GSK598809
    • Drug: Placebo
  • Experimental: Subjects receiving treatment sequence BACD
    Subjects will receive treatment sequence BACD; B= GSK598809 dose 1 (75 milligrams), A= placebo, C = GSK598809 dose 2 and D = GSK598809 dose 3
    Interventions:
    • Drug: GSK598809
    • Drug: Placebo
  • Experimental: Subjects receiving treatment sequence BCAD
    Subjects will receive treatment sequence BCAD; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, A= placebo and D = GSK598809 dose 3.
    Interventions:
    • Drug: GSK598809
    • Drug: Placebo
  • Experimental: Subjects receiving treatment sequence BCDA
    Subjects will receive treatment sequence BCDA; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, D = GSK598809 dose 3 and A= placebo.
    Interventions:
    • Drug: GSK598809
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
August 19, 2008
August 19, 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00728052
DAN111282
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP