Healthy determined by physician based on history, physical examination, lab tests and cardiac monitoring
Item
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 considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. The investigator may discuss with GSK medical monitor as required.
boolean
C3898900 (UMLS CUI [1,1])
C0521095 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0022885 (UMLS CUI [4,1])
C0205307 (UMLS CUI [4,2])
C0150496 (UMLS CUI [5,1])
C0205307 (UMLS CUI [5,2])
Gender and Age
Item
Male or female between 18 and 55 years of age inclusive
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Females: Premenopausal of no childbearing potential or postmenopausal
Item
A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and elevated FSH as per the local laboratory guidelines.
boolean
C0232969 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
Normal creatinine clearance by Cockcroft-Gault formula, serum creatinine, urine microscopy and no significant proteinuria by dipstick
Item
Normal creatinine clearance values at screening (calculated from serum creatinine by a predicting equation using Cockcroft-Gault formula), normal serum creatinine value as defined by the local reference laboratory, normal urine microscopy and no significant proteinuria on dipstick testing.
boolean
C0205307 (UMLS CUI [1,1])
C2711451 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0205307 (UMLS CUI [3,1])
C0430397 (UMLS CUI [3,2])
C0430370 (UMLS CUI [4,1])
C0033687 (UMLS CUI [4,2])
C1273937 (UMLS CUI [4,3])
Male contraception during trial period
Item
Male subjects 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 medication until the last follow-up visit.
boolean
C0086580 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
Body weight and BMI
Item
Body weight >= 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Normal spirometry (FEV1 and FEV1/FVC ratio, predictions by ECCS equations)
Item
Normal spirometry (FEV1 >= 80% of predicted, FEV1/FVC ratio >= 70%) at screening. Predictions should be according to ECCS equations, and race corrections should be made for non-caucasians.
boolean
C0855776 (UMLS CUI [1])
C0849974 (UMLS CUI [2])
C3815113 (UMLS CUI [3])
C0524592 (UMLS CUI [4,1])
C0588029 (UMLS CUI [4,2])
C0587876 (UMLS CUI [5,1])
C0524592 (UMLS CUI [5,2])
Informed Consent and Compliance
Item
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Available to complete all study assessments
Item
Available to complete all study assessments.
boolean
C0085732 (UMLS CUI [1,1])
C1999232 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
English language reading/writing/comprehension skills
Item
Able to read, comprehend and write English at a sufficient level to complete study related materials.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0584993 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
History of Hepatitis B/C or HIV, or recent positive HIV, HBsAg or HCV antibody test
Item
A history of Hepatitis B, Hepatitis C or HIV infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
boolean
C0019693 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0332185 (UMLS CUI [4,1])
C0019699 (UMLS CUI [4,2])
C0332185 (UMLS CUI [5,1])
C0149709 (UMLS CUI [5,2])
C0332185 (UMLS CUI [6,1])
C0281863 (UMLS CUI [6,2])
Current or chronic liver disease, known hepatic or biliary abnormalities, other than Gilbert's syndrome or asymptomatic gallstones
Item
Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones).
boolean
C0521116 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0341439 (UMLS CUI [2])
C4021780 (UMLS CUI [3,1])
C0205309 (UMLS CUI [3,2])
C0549613 (UMLS CUI [4,1])
C0205309 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0017551 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0231221 (UMLS CUI [6,2])
C0008350 (UMLS CUI [6,3])
Positive pre-study drug/alcohol screen
Item
A positive pre-study drug/alcohol screen.
boolean
C0743295 (UMLS CUI [1,1])
C1527048 (UMLS CUI [1,2])
C1527048 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0420032 (UMLS CUI [2,3])
Previous or active mycobacterium tuberculosis complex infection, and/or positive QuantiFERON Gold test
Item
Evidence of previous or active mycobacterium tuberculosis complex infection (including positive medical history) and/or a positive QuantiFERON TB Gold test.
boolean
C1032649 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C1032649 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C1875713 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
Recent history of and/or positive IgM for Toxoplasma consistent with active toxoplasmosis
Item
Recent history of and/or a positive test (IgM) for Toxoplasma consistent with active toxoplasmosis infection.
boolean
C0040558 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0370075 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0040558 (UMLS CUI [2,3])
C2707252 (UMLS CUI [2,4])
Recent positive RT-PCR test for influenza A/B
Item
A positive RT-PCR test for influenza A/B taken within 7 days before dosing
boolean
C0332185 (UMLS CUI [1,1])
C0029347 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,3])
C1446409 (UMLS CUI [1,4])
C0332185 (UMLS CUI [2,1])
C0029348 (UMLS CUI [2,2])
C0599161 (UMLS CUI [2,3])
C1446409 (UMLS CUI [2,4])
Current or recent influenza-like illness with fever, cough, sore throat, runny nose, sneezing, limb/joint pain, headache, vomiting/diarrhoea without known cause, other than influenza
Item
Current evidence or history of an influenza-like illness as defined by fever (>38 degrees C) and two or more of the following symptoms within 7 days before dosing: cough, sore throat, runny nose, sneezing, limb/joint pain, headache, vomiting/diarrhoea in the absence of a known cause, other than influenza.
boolean
C0332185 (UMLS CUI [1,1])
C0521839 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0521839 (UMLS CUI [2,2])
C0015967 (UMLS CUI [3])
C0010200 (UMLS CUI [4])
C0231528 (UMLS CUI [5])
C0242429 (UMLS CUI [6])
C0003862 (UMLS CUI [7])
C0037383 (UMLS CUI [8])
C1260880 (UMLS CUI [9])
C0018681 (UMLS CUI [10])
C0042963 (UMLS CUI [11,1])
C0439673 (UMLS CUI [11,2])
C0015127 (UMLS CUI [11,3])
C0011991 (UMLS CUI [12,1])
C0439673 (UMLS CUI [12,2])
C0015127 (UMLS CUI [12,3])
C1705847 (UMLS CUI [13,1])
C0021400 (UMLS CUI [13,2])
Corrected QT interval by QTcF method
Item
Corrected QT interval (QTcF) >450msec.
boolean
C0855331 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
Recent regular alcohol consumption by units per week
Item
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.
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0560579 (UMLS CUI [2])
Unwilling to abstain from alcohol consumption
Item
The subject is unwilling to abstain from alcohol consumption from 24 hr prior to dosing until discharge from the clinic, and for 24 hr prior to all other out-patient clinic visits.
boolean
C3843422 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0001948 (UMLS CUI [1,3])
Recent smoking history by cigarettes per day
Item
Subjects with a smoking history of >10 cigarettes per day in the last 3 months.
boolean
C1519384 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C3694146 (UMLS CUI [2])
Recent clinical trial participation with recent investigational product administration, or recent exposure to number of investigational products
Item
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: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) or exposure to more than four new chemical or biological entities within 12 months prior to the first dosing day.
boolean
C2348568 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0332185 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C0449788 (UMLS CUI [3,3])
C0304229 (UMLS CUI [3,4])
Recent or planned vaccination
Item
Subjects having received any type of vaccination within 3 weeks of the anticipated dosing event or are expected to be vaccinated within 3 weeks post last dose.
boolean
C0042196 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Current infection, history of repeated or chronic significant infections or recent history of serious infection
Item
Current evidence of ongoing or acute infection, history of repeated or chronic significant infections or history of serious infection within three months of randomisation.
boolean
C0521116 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C0009450 (UMLS CUI [2,3])
C0332185 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
C0009450 (UMLS CUI [3,4])
C0332185 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0009450 (UMLS CUI [4,3])
History of or current asthma, COPD, other respiratory conditions or recurrent respiratory infections
Item
Subjects who have asthma or a history of asthma, COPD, other respiratory conditions or recurrent infections
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0024117 (UMLS CUI [3,2])
C0521116 (UMLS CUI [4,1])
C0024117 (UMLS CUI [4,2])
C0262926 (UMLS CUI [5,1])
C0205394 (UMLS CUI [5,2])
C0024115 (UMLS CUI [5,3])
C0521116 (UMLS CUI [6,1])
C0205394 (UMLS CUI [6,2])
C0024115 (UMLS CUI [6,3])
C0262926 (UMLS CUI [7,1])
C0521346 (UMLS CUI [7,2])
C0239998 (UMLS CUI [7,3])
C0521116 (UMLS CUI [8,1])
C0521346 (UMLS CUI [8,2])
C0239998 (UMLS CUI [8,3])
History of migraine or frequent other headache requiring medication
Item
Subjects who have a known history of migraine headaches or are frequently suffering from other types of headaches which require medication (frequent defined as more than one headache in a fortnight).
boolean
C0262926 (UMLS CUI [1,1])
C0149931 (UMLS CUI [1,2])
C0948396 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0013216 (UMLS CUI [2,4])
Recent prescription or non-prescription drugs, vitamins, herbal and dietary supplements, St Johns Wort, except simple analgesics and those considered safe and not interfering with study participation
Item
Use of prescription or non-prescription drugs (except simple analgesics), including vitamins, herbal and dietary supplements (including St Johns Wort) within 7 days or 5 halflives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
boolean
C0332185 (UMLS CUI [1,1])
C0013231 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0304227 (UMLS CUI [2,2])
C0332185 (UMLS CUI [3,1])
C0042890 (UMLS CUI [3,2])
C0332185 (UMLS CUI [4,1])
C1504473 (UMLS CUI [4,2])
C0332185 (UMLS CUI [5,1])
C0242295 (UMLS CUI [5,2])
C0332185 (UMLS CUI [6,1])
C0813171 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0002771 (UMLS CUI [7,2])
C0205352 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0013227 (UMLS CUI [8,2])
C0750591 (UMLS CUI [8,3])
C0332197 (UMLS CUI [8,4])
C0521102 (UMLS CUI [8,5])
C2348568 (UMLS CUI [8,6])
C1705847 (UMLS CUI [9,1])
C0013227 (UMLS CUI [9,2])
C0332197 (UMLS CUI [9,3])
C0392760 (UMLS CUI [9,4])
C1113679 (UMLS CUI [9,5])
Sensitivity to study medication or components thereof, or a history of drug or other allergy including severe allergic reaction, angio-edema or anaphylaxis contraindicating participation
Item
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy including severe allergic reaction, angio-edema or anaphylaxis that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0205394 (UMLS CUI [4,1])
C0020517 (UMLS CUI [4,2])
C1301624 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
C0439793 (UMLS CUI [5,1])
C1527304 (UMLS CUI [5,2])
C1301624 (UMLS CUI [5,3])
C2348568 (UMLS CUI [5,4])
C0002994 (UMLS CUI [6,1])
C1301624 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C0002792 (UMLS CUI [7,1])
C1301624 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
History of malignancy, except for adequately treated non-invasive basal or squamous cell skin cancer or cervical carcinoma in situ
Item
History of malignancy, except for adequately treated non-invasive cancer of the skin (basal or squamous cell) or cervical carcinoma in situ (>2 yrs prior to dosing).
boolean
C0006826 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0751676 (UMLS CUI [2,2])
C0205303 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0205411 (UMLS CUI [2,5])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0205303 (UMLS CUI [3,3])
C0087111 (UMLS CUI [3,4])
C0205411 (UMLS CUI [3,5])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0205411 (UMLS CUI [4,4])
Study participation would mean excessive blood donation
Item
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 3 month or 90 day period.
boolean
C2348568 (UMLS CUI [1,1])
C0005794 (UMLS CUI [1,2])
Travel to areas with high prevalence TB or other prevalent infectious disease
Item
Subject is unable to refrain from travelling to countries with a high prevalence of TB or other areas of prevalent infectious disease as judged by the investigator or medical monitor from the start of screening until the final follow-up visit.
boolean
C0040802 (UMLS CUI [1,1])
C1512456 (UMLS CUI [1,2])
C0041296 (UMLS CUI [1,3])
C0040802 (UMLS CUI [2,1])
C0220900 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0009450 (UMLS CUI [2,4])
Mentally or legally incapacitated
Item
Subject is mentally or legally incapacitated.
boolean
C1306341 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Positive for GSK1995057 ADAs
Item
Subjects with a positive screening result for GSK1995057 ADAs
boolean
C1514241 (UMLS CUI [1,1])
C3811629 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])