ID

38913

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 information on protocol deviations, and is filled in by the Sponsor's (GSK) monitoring staff only.

Link

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

Keywords

Versions (2)
  1. 10/25/19 10/25/19 -
  2. 11/12/19 11/12/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

November 12, 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

Protocol Deviation

1 forms  
  1. StudyEvent: ODM
    1. Protocol Deviation
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Protocol Deviations
Description

Protocol Deviations

Alias
UMLS CUI-1
C1705236
Protocol Deviation Number
Description

Protocol Deviation Number

Data type

integer

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0600091
Please select Study Day
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1]
C2826182
Protocol deviation
Description

[hidden] Specify Other protocol deviation below; select sub-category for Visit window, Administer/Dispense Study Medication, Study Treatment Supply Procedures, Biological Specimen Sample Procedures, Equipment Procedures, Randomization Procedures

Data type

text

Alias
UMLS CUI [1]
C1705236
Specify other protocol deviation
Description

Specify other protocol deviation

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1705236
UMLS CUI [1,3]
C1521902
Protocol deviation: Visit window: Please select sub-category
Description

Protocol deviation: Visit

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0545082
Specify other Protocol Deviation in Visit Window category
Description

Specify other Protocol Deviation: Visit

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1705236
UMLS CUI [1,4]
C0545082
Protocol Deviation in Administer/Dispense Study Medication category: Please select sub-category
Description

Protocol Deviation: Administration/Dispensing Study Medication

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C1880359
UMLS CUI [1,3]
C0304229
UMLS CUI [2,1]
C1705236
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0304229
Specify other Protocol Deviation in Administration/Dispensing Study Medication category
Description

Specify other Protocol Deviation: Administration/Dispensing Study Medication

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1705236
UMLS CUI [1,4]
C1880359
UMLS CUI [1,5]
C0304229
UMLS CUI [2,1]
C1521902
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C1705236
UMLS CUI [2,4]
C1533734
UMLS CUI [2,5]
C0304229
Protocol Deviation in Study Treatment Supply Procedures category: Please select sub-category
Description

Protocol Deviation: Study Treatment Supply

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0243163
UMLS CUI [1,3]
C0304229
Specify other Protocol Deviation in Study Treatment Supply Procedures category
Description

Specify other Protocol Deviation: Study Treatment Supply

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1705236
UMLS CUI [1,4]
C0243163
UMLS CUI [1,5]
C0304229
Protocol Deviation in Biological Specimen Sample Procedures category: Please select sub-category
Description

Protocol Deviation: Biological Specimens

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C2347026
Specify other Protocol Deviation in Biological Specimen Sample Procedures category
Description

Specify other Protocol Deviation: Biological Specimens

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1705236
UMLS CUI [1,4]
C2347026
Protocol Deviation in Equipment Procedures category: Please select sub-category
Description

Protocol Deviation: Equipment

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0014672
Specify other Protocol Deviation in Equipment Procedures category
Description

Specify other Protocol Deviation: Equipment

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1705236
UMLS CUI [1,4]
C0014672
Protocol Deviation in Randomization Procedures category: Please select sub-category
Description

Protocol Deviation: Randomization

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0034656
Specify other Protocol Deviation in Randomization Procedures category
Description

Specify other Protocol Deviation: Randomization

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1705236
UMLS CUI [1,4]
C0034656
Protocol deviation description
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0678257
Date protocol deviation identified
Description

[hidden]

Data type

partialDate

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1880355
UMLS CUI [1,3]
C1705236
Actions taken
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C1547656
Escalated to GSK Physician for Medical Oversight?
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0031831
UMLS CUI [1,3]
C2347796
UMLS CUI [1,4]
C1283169
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Similar models

Protocol Deviation

1 forms
  1. StudyEvent: ODM
    1. Protocol Deviation
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])
Item Group
Protocol Deviations
C1705236 (UMLS CUI-1)
Protocol Deviation Number
Item
Protocol Deviation Number
integer
C1705236 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Please select Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Please select Study Day
CL Item
Screening (1)
CL Item
Day-1 (2)
CL Item
Day 1 (3)
CL Item
Day 2 (4)
CL Item
Day 3 (5)
CL Item
Day 4 (6)
CL Item
Day 5 (7)
CL Item
Day 6 (8)
CL Item
Day 7 (9)
CL Item
through Day 14 (10)
CL Item
through Day 28 (11)
CL Item
through Day 33 (12)
CL Item
through Day 56 (13)
CL Item
through Day 84 (14)
CL Item
Early Withdrawl (15)
Item
Protocol deviation
text
C1705236 (UMLS CUI [1])
Protocol deviation
Code List
Protocol deviation
CL Item
Eligibility Criteria not met (1)
CL Item
Not withdrawn after developing withdrawal critieria (2)
CL Item
Visit window (6)
CL Item
Informed consent procedure (7)
CL Item
Prohibited Medication or Device (8)
CL Item
Administer/Dispense Study Medication (9)
CL Item
Failure to report SAE, Pregnancy or liver function abnormalities per protocol (10)
CL Item
Study Treatment Supply Procedures (12)
CL Item
Biological Specimen Sample Procedures (13)
CL Item
Assessment Procedures (14)
CL Item
Equipment Procedures (16)
CL Item
Randomization Procedures (17)
CL Item
Other protocol deviation, specify (OT)
Specify other protocol deviation
Item
Specify other protocol deviation
text
C0205394 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Protocol deviation: Visit window: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Protocol deviation: Visit window
Code List
Protocol deviation: Visit window: Please select sub-category
CL Item
Visit not conducted per visit schedule (6a)
CL Item
Visit not within visit window (6b)
CL Item
Missed visit (6c)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Visit
Item
Specify other Protocol Deviation in Visit Window category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Item
Protocol Deviation in Administer/Dispense Study Medication category: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C1880359 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1705236 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2,3])
Protocol Deviation: Administration/Dispensing Study Medication
Code List
Protocol Deviation in Administer/Dispense Study Medication category: Please select sub-category
CL Item
Subject received wrong treatment (9a)
CL Item
Subject received incorrect dose (9b)
CL Item
Treatment not prepared or administered per protocol (9c)
CL Item
Subject received expired treatment (9d)
CL Item
Subject received treatment not stored as per protocol (9e)
CL Item
Subject not compliant (9f)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Administration/Dispensing Study Medication
Item
Specify other Protocol Deviation in Administration/Dispensing Study Medication category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C1880359 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C1521902 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1705236 (UMLS CUI [2,3])
C1533734 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
Item
Protocol Deviation in Study Treatment Supply Procedures category: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C0243163 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Protocol Deviation: Study Treatment Supply
Code List
Protocol Deviation in Study Treatment Supply Procedures category: Please select sub-category
CL Item
Study treatment accountability not performed as per protocol (12a)
CL Item
Study treatment disposal not performed as per protocol (12b)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Study Treatment Supply
Item
Specify other Protocol Deviation in Study Treatment Supply Procedures category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0243163 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
Item
Protocol Deviation in Biological Specimen Sample Procedures category: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C2347026 (UMLS CUI [1,2])
Protocol Deviation: Biological Specimens
Code List
Protocol Deviation in Biological Specimen Sample Procedures category: Please select sub-category
CL Item
Biological Specimen Sample Collection not performed per protocol (13a)
CL Item
Biological Specimen Sample Labelling not performed per protocol (13b)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Biological Specimens
Item
Specify other Protocol Deviation in Biological Specimen Sample Procedures category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C2347026 (UMLS CUI [1,4])
Item
Protocol Deviation in Equipment Procedures category: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C0014672 (UMLS CUI [1,2])
Protocol Deviation: Equipment
Code List
Protocol Deviation in Equipment Procedures category: Please select sub-category
CL Item
Calibration or maintenance of equipment not performed as per protocol (16a)
CL Item
Equipment not functioning (16b)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Equipment
Item
Specify other Protocol Deviation in Equipment Procedures category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0014672 (UMLS CUI [1,4])
Item
Protocol Deviation in Randomization Procedures category: Please select sub-category
text
C1705236 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Protocol Deviation: Randomization
Code List
Protocol Deviation in Randomization Procedures category: Please select sub-category
CL Item
Subject not randomized per protocol (17a)
CL Item
Other, specify (OT)
Specify other Protocol Deviation: Randomization
Item
Specify other Protocol Deviation in Randomization Procedures category
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,4])
Protocol deviation description
Item
Protocol deviation description
text
C1705236 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Date protocol deviation discovered
Item
Date protocol deviation identified
partialDate
C0011008 (UMLS CUI [1,1])
C1880355 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
Actions taken due to Protocol Deviation
Item
Actions taken
text
C1705236 (UMLS CUI [1,1])
C1547656 (UMLS CUI [1,2])
Item
Escalated to GSK Physician for Medical Oversight?
text
C1705236 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C1283169 (UMLS CUI [1,4])
Protocol Deviation sent to sponsor physician for monitoring?
Code List
Escalated to GSK Physician for Medical Oversight?
CL Item
Yes (Y)
CL Item
No (N)
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