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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00411814




Registration number
NCT00411814
Ethics application status
Date submitted
14/12/2006
Date registered
15/12/2006
Date last updated
19/03/2012

Titles & IDs
Public title
A Study Of GSK679586A When Infused Into Healthy And Mild Asthmatic Volunteers
Scientific title
A Dose-escalating Study of the Safety and Pharmacokinetics of GSK679586A in Healthy Volunteers and Mild Asthmatics.
Secondary ID [1] 0 0
I13105054
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK679586
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Saline

Active Comparator: Active - GSK679586


Treatment: Drugs: GSK679586
Active Drug

Treatment: Drugs: Placebo
Saline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis
Timepoint [1] 0 0
Throughout the study
Primary outcome [2] 0 0
Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis.
Timepoint [2] 0 0
Throughout the study
Secondary outcome [1] 0 0
Blood sampling
Timepoint [1] 0 0
Throughout the study
Secondary outcome [2] 0 0
Effects on blood and lung function.
Timepoint [2] 0 0
Throughout the study
Secondary outcome [3] 0 0
Lung function
Timepoint [3] 0 0
Throughout the study
Secondary outcome [4] 0 0
Plasma levels of GSK679586A to determine pharmacokinetic parameters
Timepoint [4] 0 0
Throughout the study
Secondary outcome [5] 0 0
serum antibodies to GSK679586A
Timepoint [5] 0 0
Throughout the study

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [2] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00411814
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00411814