ID
38588
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 whenever an ECG reading is abnormal.
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Keywords
Versions (1)
- 10/25/19 10/25/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 25, 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
ECG Abnormalities
- StudyEvent: ODM
Description
Rhythm
Alias
- UMLS CUI-1
- C0232187
Description
Sinus bradycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0085610
Description
Sinus bradycardia (heart rate 40-50 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (heart rate 30-39 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (heart rate <30 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus pause
Data type
boolean
Alias
- UMLS CUI [1]
- C1955864
Description
Sinus tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0039239
Description
Ectopic supraventricular beats
Data type
boolean
Alias
- UMLS CUI [1]
- C0033036
Description
Ectopic supraventricular rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C2348376
Description
Wandering atrial pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C1321523
Description
Multifocal atrial tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0221158
Description
Supraventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Description
Atrial flutter
Data type
boolean
Alias
- UMLS CUI [1]
- C0004239
Description
Atrial fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004238
Description
Junctional rhythm (heart rate <= 100 beats/min)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Description
Junctional rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C0232208
Description
Junctional tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0039235
Description
Ectopic ventricular beats
Data type
boolean
Alias
- UMLS CUI [1]
- C0151636
Description
Ventricular couplets
Data type
boolean
Alias
- UMLS CUI [1]
- C0429001
Description
Bigeminy
Data type
boolean
Alias
- UMLS CUI [1]
- C0262662
Description
Trigeminy
Data type
boolean
Alias
- UMLS CUI [1]
- C0428999
Description
Electrical alternans
Data type
boolean
Alias
- UMLS CUI [1]
- C1142551
Description
R on T phenomenon
Data type
boolean
Alias
- UMLS CUI [1]
- C0877658
Description
Ventricular fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0042510
Description
ldioventricular rhythm
Data type
boolean
Alias
- UMLS CUI [1]
- C0700363
Description
Sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
Non-sustained ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
Wide QRS tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344429
Description
Ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0042514
Description
Monomorphic ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344431
Description
Torsades de Pointes
Data type
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
Polymorphic ventricular tachycardia
Data type
boolean
Alias
- UMLS CUI [1]
- C0344432
Description
Artificial Pacemaker
Data type
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
Please enter comment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Description
Comment abnormal rhythm
Data type
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Description
P-Wave and QRS Morphology
Alias
- UMLS CUI-1
- C0429072
- UMLS CUI-2
- C0429098
Description
Left atrial abnormality (P mitrale)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Description
Right atrial abnormality (P pulmonale)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Description
Right ventricular hypertrophy
Data type
boolean
Alias
- UMLS CUI [1]
- C0162770
Description
Intraatrial conduction delay
Data type
boolean
Alias
- UMLS CUI [1]
- C2346510
Description
Increased voltage consistent with left ventricular hypertrophy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0332290
- UMLS CUI [1,3]
- C0149721
Description
Other morphology
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Description
Comment other morphology
Data type
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
Conduction
Alias
- UMLS CUI-1
- C0264886
Description
First degree AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C0085614
Description
Short PR interval
Data type
boolean
Alias
- UMLS CUI [1]
- C0520878
Description
Second degree AV block (Mobitz type 1)
Data type
boolean
Alias
- UMLS CUI [1]
- C0264907
Description
Second degree AV block (Mobitz type 2)
Data type
boolean
Alias
- UMLS CUI [1]
- C0155700
Description
2: 1 AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C2346542
Description
Third degree AV block
Data type
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
Left axis deviation
Data type
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
Right axis deviation
Data type
boolean
Alias
- UMLS CUI [1]
- C0232296
Description
Incomplete right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0262525
Description
Incomplete left bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0281878
Description
Right bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0085615
Description
synonymous to left anterior fascicular block
Data type
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
synonymous to left posterior fascicular block
Data type
boolean
Alias
- UMLS CUI [1]
- C0264913
Description
Left bundle branch block
Data type
boolean
Alias
- UMLS CUI [1]
- C0023211
Description
Bifascicular block
Data type
boolean
Alias
- UMLS CUI [1]
- C0264914
Description
Non-specific intraventricular conduction delay
Data type
boolean
Alias
- UMLS CUI [1]
- C3697597
Description
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Description
Prolonged QT interval
Data type
boolean
Alias
- UMLS CUI [1]
- C0151878
Description
QT/QTc prolongation by QTc time
Data type
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Description
AV dissociation
Data type
boolean
Alias
- UMLS CUI [1]
- C0004331
Description
Enter comment
Data type
boolean
Alias
- UMLS CUI [1]
- C0340494
Description
Comment other conduction abnormality
Data type
text
Alias
- UMLS CUI [1,1]
- C0340494
- UMLS CUI [1,2]
- C0947611
Description
Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Description
Myocardial infarction, old
Data type
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
Myocardial infarction, anterior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340293
Description
Myocardial infarction, lateral
Data type
boolean
Alias
- UMLS CUI [1]
- C0340312
Description
Myocardial infarction, posterior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340319
Description
Myocardial infarction, inferior
Data type
boolean
Alias
- UMLS CUI [1]
- C0340305
Description
Myocardial infarction, septal
Data type
boolean
Alias
- UMLS CUI [1]
- C0746727
Description
Myocardial infarction, Non Q-wave
Data type
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
Other myocardial infarction
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Description
Comment other myocardial infarction
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
- UMLS CUI [1,3]
- C0947611
Description
Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C2746082
- UMLS CUI-3
- C3537202
Description
Non-specific ST-T changes
Data type
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
J point elevation
Data type
boolean
Alias
- UMLS CUI [1]
- C2346597
Description
ST elevation
Data type
boolean
Alias
- UMLS CUI [1]
- C0520886
Description
ST-elevation - pericarditis
Data type
boolean
Alias
- UMLS CUI [1]
- C2348119
Description
ST depression
Data type
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
U waves abnormal
Data type
boolean
Alias
- UMLS CUI [1]
- C0438169
Description
T wave inversion
Data type
boolean
Alias
- UMLS CUI [1]
- C0520888
Description
T wave peaked
Data type
boolean
Alias
- UMLS CUI [1]
- C0239242
Description
T waves flat
Data type
boolean
Alias
- UMLS CUI [1]
- C2215959
Description
T waves biphasic
Data type
boolean
Alias
- UMLS CUI [1]
- C2348639
Description
Notched T-waves
Data type
boolean
Alias
- UMLS CUI [1]
- C2347367
Description
Low QRS voltage
Data type
boolean
Alias
- UMLS CUI [1]
- C2349945
Description
T-wave flattening/inversion
Data type
boolean
Alias
- UMLS CUI [1]
- C0520888
- UMLS CUI [2]
- C0429059
Description
Other depolarisation/repolarisation abnormality
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2746082
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0948857
Description
Comment other depolarisation/repolarisation
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C2746082
- UMLS CUI [1,4]
- C0947611
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0948857
- UMLS CUI [2,3]
- C0947611
Description
Other ECG abnormalities
Alias
- UMLS CUI-1
- C0522055
- UMLS CUI-2
- C0205394
Similar models
ECG Abnormalities
- StudyEvent: ODM
C1704258 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C1264639 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0429098 (UMLS CUI-2)
C0232310 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,2])
C0149721 (UMLS CUI [1,3])
C0332437 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
C0489625 (UMLS CUI [2])
C0947611 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C3537202 (UMLS CUI-3)
C0429059 (UMLS CUI [2])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
C0205161 (UMLS CUI [1,2])
C2746082 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])