Last updated: 11/04/2018 05:52:03
An Imaging Study to investigate the distribution of GW842166X in the brain.
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open label positron emission tomography (PET) study to investigate brain penetration by [11C]GW842166 in healthy subjects
Trial description: GW842166X is being developed for the treatment and management of inflammatory pain. GW842166X is a CB2 receptor agonist and the mechanism is not fully understood, although it is thought that for the anti-inflammatory action the drug is required to cross inot the brain from the blood. This study aims to look at if the drug crosses into the brain once given orally using an imaging technique called positron emission tomography.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Rate at which the drug crosses from plasma to brain (ki)using images from the scan
Timeframe: throughout the study
Secondary outcomes:
Safety of drug
Timeframe: after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up.
Interventions:
Drug: GW842166X
Drug: [carbonyl-^11C]GW842166
Enrollment:
6
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pain, Inflammatory
Product
GW842166
Collaborators
Not applicable
Study date(s)
June 2007 to July 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
50 - 80 years
Accepts healthy volunteers
Yes
- Male aged 50 to 80yrs inclusive at the screening visit.
- subjects with negative HIV and hepatitis B and C test results within 3 months of study start.
- A negative Allens test on arm to be used for arterial cannulation.
- Any contraindications to MRI scanning.
Inclusion and exclusion criteria
Inclusion criteria:
- Male aged 50 to 80yrs inclusive at the screening visit.
- subjects with negative HIV and hepatitis B and C test results within 3 months of study start.
Exclusion criteria:
- A negative Allens test on arm to be used for arterial cannulation.
- Any contraindications to MRI scanning.
- History or presence of hepatic or renal disease.
- Previous involvement in PET or radiological investigations.
- Family history of cancer.
- History of claustrophobia
- Presence of a cardiac pacemaker or any other electronic device or ferromagnetic metal
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-04-07
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
Participate in clinical trial
Additional information
Results for study CBA103679 can be found on the GSK Clinical Study Register.
Click hereAccess to clinical trial data by researchers
Visit website