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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00728052
First received: August 1, 2008
Last updated: March 15, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Substance Dependence
Drug: GSK598809, placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Volunteers.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: June 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: GSK598809, placebo
treatment drug
Other Names:
  • GSK598809
  • placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728052

Locations
Germany
GSK Investigational Site
Berlin, Germany, 13251
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00728052     History of Changes
Other Study ID Numbers: DAN111282
Study First Received: August 1, 2008
Last Updated: March 15, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by GlaxoSmithKline:
single
Tolerability
dose escalation
Pharmacodynamics
GSK598809
placebo
Safety
Smokers
Pharmacokinetics

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014