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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/NCT01202214
Registration number
NCT01202214
Ethics application status
Date submitted
13/09/2010
Date registered
15/09/2010
Date last updated
31/01/2011
Titles & IDs
Public title
Repeat Dose Safety Study for Compound to Treat Asthma
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Scientific title
A Randomized, Single-Blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK1440115 After a Single Dose and 7 Days of Repeat Dosing in Healthy Volunteers
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Secondary ID [1]
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UR2114661
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 1440115
Treatment: Drugs - Placebo
Experimental: Active drug -
Placebo Comparator: Placebo -
Treatment: Drugs: 1440115
Treatment: Drugs: Placebo
matching placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and tolerability assessments consisting of Adverse Events, ECGs, vital signs, clinical observations, and clinical laboratory tests
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Assessment method [1]
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Timepoint [1]
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Throughout study
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Primary outcome [2]
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Plasma drug concentration versus time curve [AUC (0-t), AUC [0-8], AUC(0-t)], maximum Cmax, tmax, and t1/2 of GSK1140115 as data permit
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Assessment method [2]
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Timepoint [2]
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Duration of dosing
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Secondary outcome [1]
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Blood pressure (BP) and heart rate (HR)
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Assessment method [1]
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Timepoint [1]
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Duration of dosing
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Secondary outcome [2]
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Peak expiratory flow rate (PEFR)
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Assessment method [2]
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Timepoint [2]
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Duration of Dosing
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Eligibility
Key inclusion criteria
1. Healthy as determined by a responsible and experienced physician, based on a medical
evaluation including medical history, physical examination, laboratory tests and
cardiac monitoring. A subject with a clinical abnormality or laboratory parameters
outside the reference range for the population being studied may be included only if
the Investigator and the GSK Medical Monitor agree that the finding is unlikely to
introduce additional risk factors and will not interfere with the study procedures.
2. Male or female between 18 and 65 years of age inclusive, at the time of signing the
informed consent.
3. A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal
ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous
amenorrhea [in questionable cases a blood sample with simultaneous follicle
stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is
confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal
status is in doubt will be required to use one of the contraception methods in Section
8.1 if they wish to continue their HRT during the study. Otherwise, they must
discontinue HRT to allow confirmation of post-menopausal status prior to study
enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the
cessation of therapy and the blood draw; this interval depends on the type and dosage
of HRT. Following confirmation of their post-menopausal status, they can resume use of
HRT during the study without use of a contraceptive method.]
4. Male subjects with female partners of child-bearing potential must agree to use one of
the contraception methods listed in Section 8.1. This criterion must be followed from
the time of the first dose of study drug until completion of the Follow-up Period.
5. Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.
6. AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated
bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin
<35%).
7. QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of Screening
2. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).
3. A positive pre-study drug/alcohol screen.
4. A positive test for HIV antibody.
5. Average systolic blood pressure of < 100 mmHg at Screening.
6. History of regular alcohol consumption within 6 months of the study defined as:
- an average weekly intake of >21 units for males or >14 units for females. One unit
is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of
wine or 1 (25 ml) measure of spirits.
7. The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).
8. Use of prescription or non-prescription medications, vitamins, and dietary or herbal
supplements (including St John's Wort) within 7 days (or 14 days if the medication is
a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first
dose of study drug, unless in the opinion of the Investigator and GSK Medical Monitor
the medication will not interfere with the study procedures or compromise subject
safety.
9. 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 Investigator or GSK
Medical Monitor, contraindicates their participation.
10. Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.
11. Pregnant females as determined by positive serum or urine hCG test at Screening or
prior to dosing.
12. Lactating females.
13. Unwillingness or inability to follow the procedures outlined in the protocol.
14. Subject is mentally or legally incapacitated.
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Accenture
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to describe the safety and tolerability of single and repeat
oral doses of GSK1440115 in healthy volunteers.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01202214
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01202214
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