ID
38915
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 is to be filled in if Liver Imaging was performed as a result of an Adverse Liver Event. There are seperate forms for general information on the Adverse Liver Event and the Liver Biopsy (if performed).
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Keywords
Versions (2)
- 10/26/19 10/26/19 -
- 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
Liver Imaging
- StudyEvent: ODM
Description
Liver imaging - General
Alias
- UMLS CUI-1
- C2711860
Description
if other, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1275506
Description
Specify other liver imaging method
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1275506
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
if other, specify
Data type
text
Alias
- UMLS CUI [1]
- C0806487
Description
Specify other image quality
Data type
text
Alias
- UMLS CUI [1,1]
- C0806487
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
If other, specify
Data type
text
Alias
- UMLS CUI [1]
- C0426688
Description
Specify other liver size
Data type
text
Alias
- UMLS CUI [1,1]
- C0426688
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
If other, specify
Data type
text
Alias
- UMLS CUI [1]
- C1285481
Description
Specify other liver texture
Data type
text
Alias
- UMLS CUI [1,1]
- C1285481
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
if other, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C1517526
Description
Specify other diffuse and/or geographic fatty infiltrate of the liver
Data type
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C1517526
- UMLS CUI [2,3]
- C0205394
- UMLS CUI [2,4]
- C2348235
Description
if other, specify
Data type
text
Alias
- UMLS CUI [1]
- C0003962
Description
Specify other ascites
Data type
text
Alias
- UMLS CUI [1,1]
- C0003962
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Are Focal Hepatic Lesions characterisable?
Alias
- UMLS CUI-1
- C0577053
- UMLS CUI-2
- C0205234
Description
If characterisable, check all that apply in next questions
Data type
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205208
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205207
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0018916
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0020510
Description
if applicable please specify
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Description
if applicable
Data type
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Gallstones or gallbladder lesions?
Alias
- UMLS CUI-1
- C0008350
- UMLS CUI-3
- C0016976
- UMLS CUI-4
- C0221198
Description
If present, check all that apply in next questions
Data type
text
Alias
- UMLS CUI [1]
- C0008350
- UMLS CUI [2,1]
- C0016976
- UMLS CUI [2,2]
- C0221198
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C0008350
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C0262493
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C0860209
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C0744257
- UMLS CUI [2,1]
- C0734014
- UMLS CUI [2,2]
- C0013604
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0734014
- UMLS CUI [1,2]
- C0333139
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C0008325
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0734014
- UMLS CUI [1,2]
- C1533591
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C3874422
Description
if applicable please specify
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0008350
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0016976
- UMLS CUI [2,3]
- C0221198
Description
if applicable
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C0008350
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C2348235
- UMLS CUI [2,3]
- C0016976
- UMLS CUI [2,4]
- C0221198
Description
Biliary ductal lesions?
Alias
- UMLS CUI-1
- C0005423
- UMLS CUI-2
- C0221198
Description
If present, check all that apply in next questions
Data type
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0700124
- UMLS CUI [1,3]
- C0227481
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0700124
- UMLS CUI [1,3]
- C0227486
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0700124
- UMLS CUI [1,3]
- C0227486
- UMLS CUI [2,1]
- C0005401
- UMLS CUI [2,2]
- C0700124
- UMLS CUI [2,3]
- C0227481
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0700124
- UMLS CUI [1,2]
- C0206187
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0700124
- UMLS CUI [2,1]
- C0700124
- UMLS CUI [2,2]
- C0206187
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C0267917
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C0566602
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C0701818
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1512083
- UMLS CUI [1,2]
- C0332555
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0242216
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0442069
- UMLS CUI [1,3]
- C0205400
- UMLS CUI [2,1]
- C0005423
- UMLS CUI [2,2]
- C0442069
- UMLS CUI [2,3]
- C0013604
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C0008340
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0577559
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205101
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C0332260
- UMLS CUI [1,4]
- C0005400
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0205394
Description
if applicable
Data type
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Portal/Hepatic vein abnormalities?
Alias
- UMLS CUI-1
- C0019155
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0032718
Description
If present, check all that apply in next questions
Data type
text
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0032718
- UMLS CUI [2,2]
- C1704258
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0700124
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C0700124
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333204
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C1265798
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C1265798
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0205282
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C0205282
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C1183135
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C0205090
- UMLS CUI [1,3]
- C0032718
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C0205091
- UMLS CUI [1,3]
- C0032718
Description
if applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C0856761
Description
if applicable please specify
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0019155
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0032718
- UMLS CUI [2,3]
- C1704258
Description
if applicable
Data type
text
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
- UMLS CUI [2,1]
- C0032718
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [2,3]
- C0205394
- UMLS CUI [2,4]
- C2348235
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- StudyEvent: ODM
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C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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C1517526 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205234 (UMLS CUI-2)
C0205234 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,2])
C0205208 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0205207 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0018916 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0020510 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0016976 (UMLS CUI-3)
C0221198 (UMLS CUI-4)
C0016976 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0734014 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
C0333139 (UMLS CUI [1,2])
C1533591 (UMLS CUI [1,2])
C0008350 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C0016976 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])
C2348235 (UMLS CUI [1,2])
C0008350 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0016976 (UMLS CUI [2,3])
C0221198 (UMLS CUI [2,4])
C0221198 (UMLS CUI-2)
C0221198 (UMLS CUI [1,2])
C0700124 (UMLS CUI [1,2])
C0227481 (UMLS CUI [1,3])
C0700124 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C0700124 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C0005401 (UMLS CUI [2,1])
C0700124 (UMLS CUI [2,2])
C0227481 (UMLS CUI [2,3])
C0206187 (UMLS CUI [1,2])
C0700124 (UMLS CUI [1,2])
C0700124 (UMLS CUI [2,1])
C0206187 (UMLS CUI [2,2])
C0332555 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0242216 (UMLS CUI [1,4])
C0442069 (UMLS CUI [1,2])
C0205400 (UMLS CUI [1,3])
C0005423 (UMLS CUI [2,1])
C0442069 (UMLS CUI [2,2])
C0013604 (UMLS CUI [2,3])
C0577559 (UMLS CUI [1,2])
C0577559 (UMLS CUI [1,2])
C0332260 (UMLS CUI [1,3])
C0005400 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1704258 (UMLS CUI-2)
C0032718 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0700124 (UMLS CUI [1,2])
C0700124 (UMLS CUI [1,2])
C0333204 (UMLS CUI [1,2])
C1265798 (UMLS CUI [1,2])
C1265798 (UMLS CUI [1,2])
C0205282 (UMLS CUI [1,2])
C0205282 (UMLS CUI [1,2])
C1183135 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
C0205091 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])