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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00439881 |
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Date of registration:
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23/02/2007 |
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Primary sponsor: |
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Public title:
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A Study To Look At The Safety Of SB-681323 In Healthy Adult Subjects After Intravenous Administration Of A Single Dose
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Scientific title:
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A Study to Assess the Safety and Tolerability of SB-681323 Administered Via the Intravenous Route |
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Date of first enrolment:
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October 2006 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00439881 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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.
Age minimum:
25 Years
Age maximum:
55 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Inflammation
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Intervention(s)
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Drug: SB-681323
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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RA1107570
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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