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NCT Number: NCT00728052

A Human Volunteer Study Investigating Single Oral Doses 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.

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Key information

Conditions

Substance Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Berlin, 13251, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK598809

Drug

GSK598809 capsules will be available with dose strengths of 5 milligrams and 25 milligrams, administered orally with water.

Placebo

Drug

Placebo capsules will be administered orally with water.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 5, 2008
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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