Arthritis, RheumatoidPhase 1NCT00439881
A Study To Look At The Safety Of SB-681323 In Healthy Adult Subjects After Intravenous Administration Of A Single Dose
A Phase 1 study testing SB-681323 in people with Arthritis, Rheumatoid and Inflammation, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
SB-681323 inhibits the action of an enzyme which is known to contribute to the inflammation seen in such conditions as Chronic Obstructive Pulmonary Disease and Rheumatoid Arthritis. This study will explore the safety of this drug and its blood levels when given in intravenous form to healthy human volunteers. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid, Inflammation
- What is being tested?
- SB-681323
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2006to not given
- 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 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy male aged between 25 and 55 years, inclusive, at the time of screening.
- Body weight = 60 kg and a Body Mass Index within the range of 19 to 32 kg/m2 inclusive.
- Must have given informed consent and signed the study consent form prior to taking part in any study procedures.
- Have no significant abnormality on clinical examination.
- Show no abnormality on haematology, clinical chemistry or urinalysis examination at the pre-study medical examination.
- Demonstrate a clinically normal 12-lead ECG at screening
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- Liver function tests within the reference range at screening (ALT, AST, ALP, GT and bilirubin)
- Do not show evidence of pre-study HIV and hepatitis B and C at screening
- Do not show a positive pre-study urine drug screen
Who cannot join
- Taken prescription or over-the-counter medication within 5 days (or 5 half lives, whichever is longer) before the first dosing day, unless the investigator confirms that it will not introduce additional risk or interfere with the study procedures or outcome.
- Show a history or evidence of drug or alcohol abuse.
- Show a history of increased liver function tests (ALT, AST, bilirubin) above upper limit of normal (ULN) in the past 6 months (if known).
- Demonstrate a history of regular alcohol consumption exceeding an average weekly intake of > 21 units (or an average daily intake of greater than 3 units). 1 unit is equivalent to a half-pint (284mL) of beer/lager; 25mL measure of spirits or 125mL of wine.
- Have a history or presence of any medically significant disease, or any disorder that would introduce additional risk or interfere with the study procedures or outcome. In particular, gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Exposure prior to the first dosing day to more than 3 new medicinal entities within 12 months or has participated in a study with a new medicinal entity within 3 months or any other study within 2 months.
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- If participation in the study will result in the subject having donated more than 450 mL blood within a 3 month period.
- On physical examination the subject is observed to have poor venous access.
- An unwillingness of subjects to abstain from sexual intercourse with women; or unwillingness of the subject to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant from the time of the first dose of investigational product until completion of the follow-up procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Safety and Tolerability of SB-681323 Administered Via the Intravenous Route
SB-681323 inhibits the action of an enzyme which is known to contribute to the inflammation seen in such conditions as Chronic Obstructive Pulmonary Disease and Rheumatoid Arthritis. This study will explore the safety of this drug and its blood levels when given in intravenous form to healthy human volunteers.
- Conditions
- Arthritis, Rheumatoid, Inflammation
- Being tested
- SB-681323
- Keywords
- inflammation,, intravenous,, Chronic Obstructive Pulmonary Disease,, P38 inhibitor, SB-681323,, rheumatoid arthritis,
- Medical subject headings
- Arthritis, Rheumatoid, Inflammation, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-681323Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of SB-681323 in terms of frequency/ nature of adverse events and changes in ECG patterns, vital signs and clinical laboratory parameters (including liver function tests) seen upto 48h after a single intravenous dose.
Secondary outcomes (1)
Regular measurements of SB-681323 blood levels upto 48h after a single intravenous dose. Effects of SB-681323 in blood samples drawn upto 24h after intravenous dosing, on laboratory tests designed to explore the anti-inflammatory properties of the drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants
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
- NCT00439881
- Sponsor's protocol ID
- RA1107570
- Status last verified
- Feb 2011
- First submitted
- 23 Feb 2007
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety and Tolerability of SB-681323 Administered Via the Intravenous Route
- ClinicalTrials.gov ID
- NCT00439881
- Acronym / sponsor ID
- RA1107570
- Conditions
- Arthritis, Rheumatoid, Inflammation
- Keywords
- inflammation,, intravenous,, Chronic Obstructive Pulmonary Disease,, P38 inhibitor, SB-681323,, rheumatoid arthritis,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 26 Feb 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.
SB-681323 inhibits the action of an enzyme which is known to contribute to the inflammation seen in such conditions as Chronic Obstructive Pulmonary Disease and Rheumatoid Arthritis. This study will explore the safety of this drug and its blood levels when given in intravenous form to healthy human volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- A healthy male aged between 25 and 55 years, inclusive, at the time of screening.
- Body weight = 60 kg and a Body Mass Index within the range of 19 to 32 kg/m2 inclusive.
- Must have given informed consent and signed the study consent form prior to taking part in any study procedures.
- Have no significant abnormality on clinical examination.
- Show no abnormality on haematology, clinical chemistry or urinalysis examination at the pre-study medical examination.
Key exclusion criteria (9 listed)
- Taken prescription or over-the-counter medication within 5 days (or 5 half lives, whichever is longer) before the first dosing day, unless the investigator confirms that it will not introduce additional risk or interfere with the study procedures or outcome.
- Show a history or evidence of drug or alcohol abuse.
- Show a history of increased liver function tests (ALT, AST, bilirubin) above upper limit of normal (ULN) in the past 6 months (if known).
- Demonstrate a history of regular alcohol consumption exceeding an average weekly intake of > 21 units (or an average daily intake of greater than 3 units). 1 unit is equivalent to a half-pint (284mL) of beer/lager; 25mL measure of spirits or 125mL of wine.
- Have a history or presence of any medically significant disease, or any disorder that would introduce additional risk or interfere with the study procedures or outcome. In particular, gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
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 |
|---|---|---|
| SB-681323 | Drug | – |
Primary outcome
Safety of SB-681323 in terms of frequency/ nature of adverse events and changes in ECG patterns, vital signs and clinical laboratory parameters (including liver function tests) seen upto 48h after a single intravenous dose.
1 secondary outcome
Regular measurements of SB-681323 blood levels upto 48h after a single intravenous dose. Effects of SB-681323 in blood samples drawn upto 24h after intravenous dosing, on laboratory tests designed to explore the anti-inflammatory properties of the drug.
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 4 Jun 2012.
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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 SB-681323 in people with Arthritis, Rheumatoid and Inflammation, run by GlaxoSmithKline at 1 site in United Kingdom.
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 9 inclusion and 9 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 4 Jun 2012. 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 United Kingdom. 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?
Safety of SB-681323 in terms of frequency/ nature of adverse events and changes in ECG patterns, vital signs and clinical laboratory parameters (including liver function tests) seen upto 48h after a single intravenous dose.. 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 4 Jun 2012.