ID

38183

Description

Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form contains the study's eligibility criteria, which are checked at the Screening Visit.

Link

https://clinicaltrials.gov/ct2/show/NCT01476046

Keywords

Versions (1)
  1. 9/24/19 9/24/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 24, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date/Time of Assessment
Description

Date/Time of Assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1264639
Eligibility Criteria
Description

Eligibility Criteria

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

If no, please select all boxes corresponding to violations of any inclusion/exclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
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.
Description

Healthy determined by physician based on history, physical examination, lab tests and cardiac monitoring

Data type

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0521095
UMLS CUI [1,3]
C0031831
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0205307
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0205307
UMLS CUI [4,1]
C0022885
UMLS CUI [4,2]
C0205307
UMLS CUI [5,1]
C0150496
UMLS CUI [5,2]
C0205307
Male or female between 18 and 55 years of age inclusive
Description

Gender and Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
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.
Description

Females: Premenopausal of no childbearing potential or postmenopausal

Data type

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0232970
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.
Description

Normal creatinine clearance by Cockcroft-Gault formula, serum creatinine, urine microscopy and no significant proteinuria by dipstick

Data type

boolean

Alias
UMLS CUI [1,1]
C0205307
UMLS CUI [1,2]
C2711451
UMLS CUI [2,1]
C0201976
UMLS CUI [2,2]
C0205307
UMLS CUI [3,1]
C0205307
UMLS CUI [3,2]
C0430397
UMLS CUI [4,1]
C0430370
UMLS CUI [4,2]
C0033687
UMLS CUI [4,3]
C1273937
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.
Description

Male contraception during trial period

Data type

boolean

Alias
UMLS CUI [1,1]
C0086580
UMLS CUI [1,2]
C2347804
Body weight >= 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
Description

Body weight and BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
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.
Description

Normal spirometry (FEV1 and FEV1/FVC ratio, predictions by ECCS equations)

Data type

boolean

Alias
UMLS CUI [1]
C0855776
UMLS CUI [2]
C0849974
UMLS CUI [3]
C3815113
UMLS CUI [4,1]
C0524592
UMLS CUI [4,2]
C0588029
UMLS CUI [5,1]
C0587876
UMLS CUI [5,2]
C0524592
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Description

Informed Consent and Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Available to complete all study assessments.
Description

Available to complete all study assessments

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1999232
UMLS CUI [1,3]
C2347804
Able to read, comprehend and write English at a sufficient level to complete study related materials.
Description

English language reading/writing/comprehension skills

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0584993
UMLS CUI [3,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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
Description

History of Hepatitis B/C or HIV, or recent positive HIV, HBsAg or HCV antibody test

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C0332185
UMLS CUI [4,2]
C0019699
UMLS CUI [5,1]
C0332185
UMLS CUI [5,2]
C0149709
UMLS CUI [6,1]
C0332185
UMLS CUI [6,2]
C0281863
Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones).
Description

Current or chronic liver disease, known hepatic or biliary abnormalities, other than Gilbert's syndrome or asymptomatic gallstones

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0023895
UMLS CUI [2]
C0341439
UMLS CUI [3,1]
C4021780
UMLS CUI [3,2]
C0205309
UMLS CUI [4,1]
C0549613
UMLS CUI [4,2]
C0205309
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0017551
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0231221
UMLS CUI [6,3]
C0008350
A positive pre-study drug/alcohol screen.
Description

Positive pre-study drug/alcohol screen

Data type

boolean

Alias
UMLS CUI [1,1]
C0743295
UMLS CUI [1,2]
C1527048
UMLS CUI [2,1]
C1527048
UMLS CUI [2,2]
C1446409
UMLS CUI [2,3]
C0420032
Evidence of previous or active mycobacterium tuberculosis complex infection (including positive medical history) and/or a positive QuantiFERON TB Gold test.
Description

Previous or active mycobacterium tuberculosis complex infection, and/or positive QuantiFERON Gold test

Data type

boolean

Alias
UMLS CUI [1,1]
C1032649
UMLS CUI [1,2]
C2707252
UMLS CUI [2,1]
C1032649
UMLS CUI [2,2]
C0009450
UMLS CUI [2,3]
C0205156
UMLS CUI [3,1]
C1875713
UMLS CUI [3,2]
C1446409
Recent history of and/or a positive test (IgM) for Toxoplasma consistent with active toxoplasmosis infection.
Description

Recent history of and/or positive IgM for Toxoplasma consistent with active toxoplasmosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0040558
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0370075
UMLS CUI [2,2]
C1446409
UMLS CUI [2,3]
C0040558
UMLS CUI [2,4]
C2707252
A positive RT-PCR test for influenza A/B taken within 7 days before dosing
Description

Recent positive RT-PCR test for influenza A/B

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0029347
UMLS CUI [1,3]
C0599161
UMLS CUI [1,4]
C1446409
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0029348
UMLS CUI [2,3]
C0599161
UMLS CUI [2,4]
C1446409
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0521839
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0521839
UMLS CUI [3]
C0015967
UMLS CUI [4]
C0010200
UMLS CUI [5]
C0231528
UMLS CUI [6]
C0242429
UMLS CUI [7]
C0003862
UMLS CUI [8]
C0037383
UMLS CUI [9]
C1260880
UMLS CUI [10]
C0018681
UMLS CUI [11,1]
C0042963
UMLS CUI [11,2]
C0439673
UMLS CUI [11,3]
C0015127
UMLS CUI [12,1]
C0011991
UMLS CUI [12,2]
C0439673
UMLS CUI [12,3]
C0015127
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0021400
Corrected QT interval (QTcF) >450msec.
Description

Corrected QT interval by QTcF method

Data type

boolean

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C1882513
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.
Description

One unit is equivalent to 8 g of alcohol and the following can be used as a guide: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0332185
UMLS CUI [2]
C0560579
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.
Description

Unwilling to abstain from alcohol consumption

Data type

boolean

Alias
UMLS CUI [1,1]
C3843422
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C0001948
Subjects with a smoking history of >10 cigarettes per day in the last 3 months.
Description

Recent smoking history by cigarettes per day

Data type

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C0332185
UMLS CUI [2]
C3694146
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.
Description

Recent clinical trial participation with recent investigational product administration, or recent exposure to number of investigational products

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C0332157
UMLS CUI [3,3]
C0449788
UMLS CUI [3,4]
C0304229
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.
Description

Recent or planned vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0332185
Current evidence of ongoing or acute infection, history of repeated or chronic significant infections or history of serious infection within three months of randomisation.
Description

Current infection, history of repeated or chronic significant infections or recent history of serious infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0009450
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0205341
UMLS CUI [2,3]
C0009450
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C0205191
UMLS CUI [3,3]
C0750502
UMLS CUI [3,4]
C0009450
UMLS CUI [4,1]
C0332185
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0009450
Subjects who have asthma or a history of asthma, COPD, other respiratory conditions or recurrent infections
Description

A subject who suffered from childhood asthma but not as an adult may be included provided they fulfil other entry criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004096
UMLS CUI [2,1]
C0521116
UMLS CUI [2,2]
C0004096
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0024117
UMLS CUI [4,1]
C0521116
UMLS CUI [4,2]
C0024117
UMLS CUI [5,1]
C0262926
UMLS CUI [5,2]
C0205394
UMLS CUI [5,3]
C0024115
UMLS CUI [6,1]
C0521116
UMLS CUI [6,2]
C0205394
UMLS CUI [6,3]
C0024115
UMLS CUI [7,1]
C0262926
UMLS CUI [7,2]
C0521346
UMLS CUI [7,3]
C0239998
UMLS CUI [8,1]
C0521116
UMLS CUI [8,2]
C0521346
UMLS CUI [8,3]
C0239998
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).
Description

History of migraine or frequent other headache requiring medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0149931
UMLS CUI [2,1]
C0948396
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0013216
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0013231
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0304227
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C0042890
UMLS CUI [4,1]
C0332185
UMLS CUI [4,2]
C1504473
UMLS CUI [5,1]
C0332185
UMLS CUI [5,2]
C0242295
UMLS CUI [6,1]
C0332185
UMLS CUI [6,2]
C0813171
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0002771
UMLS CUI [7,3]
C0205352
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0013227
UMLS CUI [8,3]
C0750591
UMLS CUI [8,4]
C0332197
UMLS CUI [8,5]
C0521102
UMLS CUI [8,6]
C2348568
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0013227
UMLS CUI [9,3]
C0332197
UMLS CUI [9,4]
C0392760
UMLS CUI [9,5]
C1113679
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0013182
UMLS CUI [3,2]
C1301624
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0205394
UMLS CUI [4,2]
C0020517
UMLS CUI [4,3]
C1301624
UMLS CUI [4,4]
C2348568
UMLS CUI [5,1]
C0439793
UMLS CUI [5,2]
C1527304
UMLS CUI [5,3]
C1301624
UMLS CUI [5,4]
C2348568
UMLS CUI [6,1]
C0002994
UMLS CUI [6,2]
C1301624
UMLS CUI [6,3]
C2348568
UMLS CUI [7,1]
C0002792
UMLS CUI [7,2]
C1301624
UMLS CUI [7,3]
C2348568
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).
Description

History of malignancy, except for adequately treated non-invasive basal or squamous cell skin cancer or cervical carcinoma in situ

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0751676
UMLS CUI [2,3]
C0205303
UMLS CUI [2,4]
C0087111
UMLS CUI [2,5]
C0205411
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C0205303
UMLS CUI [3,4]
C0087111
UMLS CUI [3,5]
C0205411
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0205411
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.
Description

Study participation would mean excessive blood donation

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0005794
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.
Description

Travel to areas with high prevalence TB or other prevalent infectious disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C1512456
UMLS CUI [1,3]
C0041296
UMLS CUI [2,1]
C0040802
UMLS CUI [2,2]
C0220900
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C0009450
Subject is mentally or legally incapacitated.
Description

Mentally or legally incapacitated

Data type

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0332268
Subjects with a positive screening result for GSK1995057 ADAs
Description

Part B only, i.e. Cohorts 4 to 7

Data type

boolean

Alias
UMLS CUI [1,1]
C1514241
UMLS CUI [1,2]
C3811629
UMLS CUI [1,3]
C0013230
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Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C1516048 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Eligibility Criteria
C1516637 (UMLS CUI-1)
Entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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])
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