Last updated: 11/04/2018 08:15:05
Study Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males
GSK study ID
HTP103265
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090
Timeframe: throughout the study
Secondary outcomes:
Vitals signs ECGs Clinical Laboratory test results
Timeframe: throughout the study
Interventions:
Drug: GSK163090
Enrollment:
13
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects, Depressive Disorder and Anxiety Disorders
Product
GSK163090
Collaborators
Not applicable
Study date(s)
November 2006 to December 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Healthy male subjects, aged 18-45 years Body weight > 50 kg
- Non-Smoker
- History of any cardiac disease
- History of regular alcohol consumption averaging >14 drinks/week
Inclusion and exclusion 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
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-06-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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