Back to resultsStudy Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males
Primary Purpose
Healthy Subjects, Depressive Disorder and Anxiety Disorders
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
GSK163090
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Subjects focused on measuring PET scan, healthy males
Eligibility Criteria
Inclusion Criteria:
- Healthy male subjects, aged 18-45 years Body weight > 50 kg
- Non-Smoker
- Normal ECG, heart rate and blood pressure
Exclusion Criteria:
- History of any cardiac disease
- History of regular alcohol consumption averaging >14 drinks/week
- Current or recent gastrointestinal disease; History of psychiatric illness including any history of suicidal attempts
- Positive for Hepatitis B and C, and HIV.
- History of drug abuse.
- Exposure to research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden
- Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
- Suffers from claustrophobia
- History or presence of neurological or psychiatric conditions
- Presence of a cardiac pacemaker or other implanted electronic device or metal implants
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
GSK163090
Arm Description
one infusion only
Outcomes
Primary Outcome Measures
Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090
Secondary Outcome Measures
Vitals signs ECGs Clinical Laboratory test results
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00435695
Brief Title
Study Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males
Official Title
An Open Label, Non-randomized Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain 5-HT1A Receptor Occupancy, Pharmacokinetics and Safety of Single Oral Doses of GSK163090, Using the Ligand [11C]-WAY100635.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to look at how much of a new drug, GSK163090, binds to proteins in the brain and how much stays in the blood over a range of different doses. This study will use a medical imaging technique called Positron Emission Tomography (PET) which uses an imaging agent called [11C]-WAY100635.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Depressive Disorder and Anxiety Disorders
Keywords
PET scan, healthy males
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK163090
Arm Type
Active Comparator
Arm Description
one infusion only
Intervention Type
Drug
Intervention Name(s)
GSK163090
Primary Outcome Measure Information:
Title
Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
Vitals signs ECGs Clinical Laboratory test results
Time Frame
throughout the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male subjects, aged 18-45 years Body weight > 50 kg
Non-Smoker
Normal ECG, heart rate and blood pressure
Exclusion Criteria:
History of any cardiac disease
History of regular alcohol consumption averaging >14 drinks/week
Current or recent gastrointestinal disease; History of psychiatric illness including any history of suicidal attempts
Positive for Hepatitis B and C, and HIV.
History of drug abuse.
Exposure to research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden
Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
Suffers from claustrophobia
History or presence of neurological or psychiatric conditions
Presence of a cardiac pacemaker or other implanted electronic device or metal implants
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
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
12. IPD Sharing Statement
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Study Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males
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