A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward
July 19, 2017 updated by: GlaxoSmithKline
A Randomized, Double-bind, Placebo Controlled, Two-way Cross-over Study to Assess the Effects of a Single Dose of GSK598809, a Selective DRD3 Antagonist, in Modulating Nicotine Reward
GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders.
This study will asses the effects of a single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male volunteers who smoke.
Each cohort of subjects will receive a single dose of placebo or GSK598809 in two dosing sessions binded crossover fashine.
There will be a washout period of at least seven days between each session.
Study Overview
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male smokers aged 18-65 with a desire to quit smoking.
- Body weight greater than 50kg and BMI within range 19 - 29.9 kg/m2
- Healthy with no significant medical, psychiatric or laboratory evaluation abnormality.
Exclusion Criteria:
- Positive pre-study urine drug/breath alcohol screen: positive HIV 1/2, Hepatitis B or Hepatitis C test at screening.
- History of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study.
- History of psychiatric disorder or sensitivity to any of the study medications or components thereof or a history of drug or allergy that in the opinion of the physician responsible contraindicates their participation.
- History of cardiac or pulmonary disease/abnormalities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: GSK598809
Drug
|
Drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pharmacokinetics
Time Frame: through 24 hours
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through 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Stroop test
Time Frame: through 10 hours
|
through 10 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2008
Primary Completion (Actual)
March 20, 2009
Study Completion (Actual)
March 20, 2009
Study Registration Dates
First Submitted
January 18, 2008
First Submitted That Met QC Criteria
January 18, 2008
First Posted (Estimate)
January 31, 2008
Study Record Updates
Last Update Posted (Actual)
July 21, 2017
Last Update Submitted That Met QC Criteria
July 19, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAN106593
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Individual Participant Data Set
Information identifier: DAN106593Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: DAN106593Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: DAN106593Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: DAN106593Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: DAN106593Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: DAN106593Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: DAN106593Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.