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Home > Protocol Summaries: Compounds > GSK618334 > Protocol Summary for 108414

Protocol Summary for 108414

Protocol Summary
Protocol Id: 108414
Secondary Ids:
  • N/A
Title: A placebo-controlled, single blind, randomized two part study toinvestigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers.
Phase: phase 1
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • United Kingdom: Medicines and Healthcare products Regulatory Agency
Collaborators:
  • N/A
Brief Summary: The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.
Detailed Description: GSK618334 strongly binds to dopamine type 3 receptors in the human brain and is being developed as an innovative treatment for substance dependence. This study will evaluate the safety, tolerability, blood concentrations and effect following repeated oral doses of GSK618334 in healthy male and female volunteers. The effect of food on a single oral dose of GSK618334 will also be evaluated. Another portion of this study will investigate dopamine type 3 receptor binding in the human brain by PET scan before and after repeated doses of GSK618334.
Record Verification Date: June 2011
Status: Completed
Why Study Stopped:
Study Start Date: September 2009
Study Completion Date: February 2010
Study Completion Date Type: Actual
Primary Completion Date: February 2010
Primary Completion Date Type: Actual
Primary Purpose: other
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: yes
Masked Assessor: no
Study Design (Assignment): Single Group Assignment
Study Classification (Endpoint): Pharmacodynamics Study
Primary Outcomes:
  • The safety and tolerability endpoints will be: adverse events, laboratory values, cardiovascular variables (blood pressure, heart rate, ECG), temperature, respiratory rate, assessment of mood and abnormal movements, and GSK618334 blood levels. yes First dose to follow-up
  • To assess blood concentrations of GSK618334 after repeated oral doses. First dose to 72 hours post last dose
Secondary Outcomes:
  • The dopamine type 3 receptor binding in the brain (by PET scan) of GSK618334 following the repeat dose session. First dose to 24 hours after last dose
  • To assess the effect of food on GSK618334 blood concentrations after a single dose. First dose of the single dose session to 24 hours after dosing of the repeat dose session
Conditions:
  • Substance Dependence
Keywords:
  • compulsive discorders
  • addiction
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 50 Year
Enrollment: 46
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information