Back to resultsA Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward
Primary Purpose
Substance Dependence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GSK598809
Sponsored by
About this trial
This is an interventional treatment trial for Substance Dependence focused on measuring pharmacodynamics,, pharmacokinetics,, tolerability,, Safety,, single dose,, placebo,, Nicotine reward, GSK598809
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
GSK598809
Arm Description
Drug
Outcomes
Primary Outcome Measures
Pharmacokinetics
Secondary Outcome Measures
Stroop test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00605241
Brief Title
A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 25, 2008 (Actual)
Primary Completion Date
March 20, 2009 (Actual)
Study Completion Date
March 20, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependence
Keywords
pharmacodynamics,, pharmacokinetics,, tolerability,, Safety,, single dose,, placebo,, Nicotine reward, GSK598809
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK598809
Arm Type
Other
Arm Description
Drug
Intervention Type
Drug
Intervention Name(s)
GSK598809
Intervention Description
Drug
Primary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
through 24 hours
Secondary Outcome Measure Information:
Title
Stroop test
Time Frame
through 10 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
22968817
Citation
Mugnaini M, Iavarone L, Cavallini P, Griffante C, Oliosi B, Savoia C, Beaver J, Rabiner EA, Micheli F, Heidbreder C, Andorn A, Merlo Pich E, Bani M. Occupancy of brain dopamine D3 receptors and drug craving: a translational approach. Neuropsychopharmacology. 2013 Jan;38(2):302-12. doi: 10.1038/npp.2012.171. Epub 2012 Sep 12.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
DAN106593
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
DAN106593
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
DAN106593
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
DAN106593
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
DAN106593
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
DAN106593
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
DAN106593
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward
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