Pain, InflammatoryPhase 1NCT00511524
An Imaging Study to Investigate the Distribution of GW842166X in the Brain.
A Phase 1 study testing GW842166X and [carbonyl-^11C]GW842166 in people with Pain, Inflammatory, run by GlaxoSmithKline at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Inflammatory
- What is being tested?
- GW842166X and [carbonyl-^11C]GW842166
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 26 Jun 2007to 4 Jul 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [11C]GW842166 in Healthy Subjects
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.
- Conditions
- Pain, Inflammatory
- Being tested
- GW842166X, [carbonyl-^11C]GW842166
- Keywords
- brain,, inflammation,, CB2,, PET, analgesia,
- Medical subject headings
- Pain, Inflammation, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW842166XDrug
GW842166X will available with dose strength of 100 mg capsules. Four 100mg GW842166X capsules will be used for the 400 mg oral dose of GW842166X.
[carbonyl-^11C]GW842166Drug
[carbonyl-^11C]GW842166 will b available as Intravenous solution.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving GW842166 | Experimental | Subjects will receive single oral dose of 400 milligram (mg) un-labeled GW842166X. After 2-5 hours subjects will receive [carbonyl-^11C]GW842166. Receives: Drug: GW842166X; Drug: [carbonyl-^11C]GW842166 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate at which the drug crosses from plasma to brain (ki)using images from the scan
Measured: throughout the study
Secondary outcomes (1)
Safety of drug
Measured: after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study start26 Jun 2007
- Primary completion4 Jul 2007
- Study completion4 Jul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, InflammatoryStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511524
- Sponsor's protocol ID
- CBA103679
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2007
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [11C]GW842166 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00511524
- Acronym / sponsor ID
- CBA103679
- Conditions
- Pain, Inflammatory
- Keywords
- brain,, inflammation,, CB2,, PET, analgesia,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2007 (actual)
- Primary completion
- 4 Jul 2007 (actual)
- Study completion
- 4 Jul 2007 (actual)
- First posted
- 6 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving GW842166 | Experimental | Drug: GW842166X, Drug: [carbonyl-^11C]GW842166Subjects will receive single oral dose of 400 milligram (mg) un-labeled GW842166X. After 2-5 hours subjects will receive [carbonyl-^11C]GW842166. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW842166XGW842166X will available with dose strength of 100 mg capsules. Four 100mg GW842166X capsules will be used for the 400 mg oral dose of GW842166X. | Drug | Subjects receiving GW842166 |
| [carbonyl-^11C]GW842166[carbonyl-^11C]GW842166 will b available as Intravenous solution. | Drug | Subjects receiving GW842166 |
Primary outcome
Rate at which the drug crosses from plasma to brain (ki)using images from the scan
Time frame: throughout the study
1 secondary outcome
Safety of drug
Time frame: after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Results for study CBA103679 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW842166X and [carbonyl-^11C]GW842166 in people with Pain, Inflammatory, run by GlaxoSmithKline at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate at which the drug crosses from plasma to brain (ki)using images from the scan (time frame: throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.