- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00411814
A Study Of GSK679586A When Infused Into Healthy And Mild Asthmatic Volunteers
March 15, 2012 updated by: GlaxoSmithKline
A Dose-escalating Study of the Safety and Pharmacokinetics of GSK679586A in Healthy Volunteers and Mild Asthmatics.
This is a two part study.
Part I is designed to test single doses of GSK678586A in healthy volunteers.
Part II is designed to test repeat doses (two doses) of GSK679586A in patients with mild asthma.
Both parts are designed to investigate the safety, tolerability and the way the body absorbs GSK679586A when given by intravenous infusion (through a vein in your arm).
Study Overview
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Randwick, New South Wales, Australia, 2031
- GSK Investigational Site
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
- Men aged 18 - 65 years inclusive, or women aged 18 - 50 years inclusive.
- Female subjects must be of non-childbearing potential,
- Male subjects must agree to abstain from sexual intercourse or use adequate contraception during sexual intercourse with pregnant or lactating females, in addition to their female partner using another form of contraception. This criterion must be followed from the time of the first dose of study medication until 84 days after the last dose of study medication.
- Body weight ≥ 50 kg and BMI within the range 19 - 29.9 kg/m2.
- Non-smoker as verified by urinary cotinine levels below 300 ng/mL at screening or ex-smokers who have given up smoking for >12 months with a history <10 pack years [Pack yrs = (No of cigarettes/day x No of years smoked)/20]
- Available to complete all study measurements.
- Able to read, comprehend, and write English at a sufficient level to complete study related materials.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Additional Inclusion Criteria for Subjects in Part I
• Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
Additional Inclusion Criteria for Subjects in Part II
- History of asthma for at least 6 months prior to the screening visit currently requiring no treatment or intermittent treatment with inhaled short-acting beta2-agonist only. Subject must not have received low dose inhaled corticosteroids within three months prior to Day 0.
- Pre-bronchodilator FEV1 >70% but <90% of predicted at screening with ≥12% reversibility after short-acting beta2-agonist or If the subject has a pre-bronchodilator FEV1 ≥90% at screening but has a history of asthma or if the subject meets the FEV1 criteria but does not demonstrate ≥12% reversibility after short-acting beta2-agonist administration, then the subject may be considered eligible if a Bronchial Provocation Test for asthma is positive (and after consultation with Medical Monitor and Principal Investigator). The bronchial provocation will be considered positive when the standard criteria for a positive response with the given challenge agent are met.
- Skin prick test positive for an allergen that is appropriate for nasal challenge
Exclusion criteria:
- As a result of medical interview, physical examination or screening investigations, the responsible physician deemed the subject unsuitable for the study.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
- Previous exposure to humanised antibody therapy for any reason.
- A strong family history of Th1 cytokine-related inflammatory disorders, including but not limited to, Type I diabetes mellitus, multiple sclerosis, Crohn's disease, rheumatoid arthritis, sarcoidosis.
- Known history of active or latent tuberculosis, or recent (within 6 months of study enrolment) exposure to a person with active tuberculosis. Previous medical history and letter from the subject's physician (GP) should exclude this.
- A history of chronic urogenital infections or other chronic infections.
- Subjects who have received any type of vaccination in the last two months.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication
- Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
- History of alcohol/drug abuse or dependence within 12 months of the study:
- Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for human immunodeficiency virus (HIV) antibodies.
- The subject has a positive pre-study urine drug/ urine alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
- ECG that is outside of ranges as defined by the protocol
- Those who, in the opinion of the Investigator, have a risk of non-compliance with study procedures.
- The subject has a history of confirmed or active parasitic infection.
- The subject is unable to refrain from travelling to countries with a high prevalence of infectious (especially parasitic) disease from when the first dose is administered until the expected washout period is complete (plasma levels below LLQ) or the last follow-up visit, which ever is later
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Saline
|
Saline
Other Names:
|
ACTIVE_COMPARATOR: Active
GSK679586
|
Active Drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis
Time Frame: Throughout the study
|
Throughout the study
|
Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis.
Time Frame: Throughout the study
|
Throughout the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood sampling
Time Frame: Throughout the study
|
Throughout the study
|
Effects on blood and lung function.
Time Frame: Throughout the study
|
Throughout the study
|
Lung function
Time Frame: Throughout the study
|
Throughout the study
|
Plasma levels of GSK679586A to determine pharmacokinetic parameters
Time Frame: Throughout the study
|
Throughout the study
|
serum antibodies to GSK679586A
Time Frame: Throughout the study
|
Throughout the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (ACTUAL)
February 1, 2008
Study Completion (ACTUAL)
February 1, 2008
Study Registration Dates
First Submitted
December 14, 2006
First Submitted That Met QC Criteria
December 14, 2006
First Posted (ESTIMATE)
December 15, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
March 19, 2012
Last Update Submitted That Met QC Criteria
March 15, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I13105054
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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