ID
38588
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT01476046
Nyckelord
Versioner (1)
- 2019-10-25 2019-10-25 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
25 oktober 2019
DOI
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Licens
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
Beskrivning
Rhythm
Alias
- UMLS CUI-1
- C0232187
Beskrivning
Sinus bradycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085610
Beskrivning
Sinus bradycardia (heart rate 40-50 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beskrivning
Sinus bradycardia (heart rate 30-39 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beskrivning
Sinus bradycardia (heart rate <30 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beskrivning
Sinus pause
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beskrivning
Sinus tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0039239
Beskrivning
Ectopic supraventricular beats
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0033036
Beskrivning
Ectopic supraventricular rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348376
Beskrivning
Wandering atrial pacemaker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1321523
Beskrivning
Multifocal atrial tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0221158
Beskrivning
Supraventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
Beskrivning
Atrial flutter
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beskrivning
Atrial fibrillation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beskrivning
Junctional rhythm (heart rate <= 100 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
Beskrivning
Junctional rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232208
Beskrivning
Junctional tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0039235
Beskrivning
Ectopic ventricular beats
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151636
Beskrivning
Ventricular couplets
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0429001
Beskrivning
Bigeminy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262662
Beskrivning
Trigeminy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0428999
Beskrivning
Electrical alternans
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1142551
Beskrivning
R on T phenomenon
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0877658
Beskrivning
Ventricular fibrillation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0042510
Beskrivning
ldioventricular rhythm
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700363
Beskrivning
Sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beskrivning
Non-sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beskrivning
Wide QRS tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0344429
Beskrivning
Ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0042514
Beskrivning
Monomorphic ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0344431
Beskrivning
Torsades de Pointes
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beskrivning
Polymorphic ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0344432
Beskrivning
Artificial Pacemaker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0030163
Beskrivning
Please enter comment
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beskrivning
Comment abnormal rhythm
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beskrivning
P-Wave and QRS Morphology
Alias
- UMLS CUI-1
- C0429072
- UMLS CUI-2
- C0429098
Beskrivning
Left atrial abnormality (P mitrale)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344711
- UMLS CUI [1,2]
- C0232310
Beskrivning
Right atrial abnormality (P pulmonale)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344696
- UMLS CUI [1,2]
- C0232308
Beskrivning
Right ventricular hypertrophy
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0162770
Beskrivning
Intraatrial conduction delay
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2346510
Beskrivning
Increased voltage consistent with left ventricular hypertrophy
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1112650
- UMLS CUI [1,2]
- C0332290
- UMLS CUI [1,3]
- C0149721
Beskrivning
Other morphology
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beskrivning
Comment other morphology
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
Conduction
Alias
- UMLS CUI-1
- C0264886
Beskrivning
First degree AV block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085614
Beskrivning
Short PR interval
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520878
Beskrivning
Second degree AV block (Mobitz type 1)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264907
Beskrivning
Second degree AV block (Mobitz type 2)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155700
Beskrivning
2: 1 AV block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2346542
Beskrivning
Third degree AV block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151517
Beskrivning
Left axis deviation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beskrivning
Right axis deviation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232296
Beskrivning
Incomplete right bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262525
Beskrivning
Incomplete left bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0281878
Beskrivning
Right bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085615
Beskrivning
synonymous to left anterior fascicular block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264912
Beskrivning
synonymous to left posterior fascicular block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264913
Beskrivning
Left bundle branch block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023211
Beskrivning
Bifascicular block
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264914
Beskrivning
Non-specific intraventricular conduction delay
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3697597
Beskrivning
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Beskrivning
Prolonged QT interval
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151878
Beskrivning
QT/QTc prolongation by QTc time
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Beskrivning
AV dissociation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beskrivning
Enter comment
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340494
Beskrivning
Comment other conduction abnormality
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0340494
- UMLS CUI [1,2]
- C0947611
Beskrivning
Myocardial Infarction
Alias
- UMLS CUI-1
- C0027051
Beskrivning
Myocardial infarction, old
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beskrivning
Myocardial infarction, anterior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340293
Beskrivning
Myocardial infarction, lateral
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340312
Beskrivning
Myocardial infarction, posterior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340319
Beskrivning
Myocardial infarction, inferior
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0340305
Beskrivning
Myocardial infarction, septal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0746727
Beskrivning
Myocardial infarction, Non Q-wave
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0542269
Beskrivning
Other myocardial infarction
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Beskrivning
Comment other myocardial infarction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
- UMLS CUI [1,3]
- C0947611
Beskrivning
Depolarisation/Repolarisation (QRS-T)
Alias
- UMLS CUI-1
- C2746082
- UMLS CUI-3
- C3537202
Beskrivning
Non-specific ST-T changes
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beskrivning
J point elevation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2346597
Beskrivning
ST elevation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520886
Beskrivning
ST-elevation - pericarditis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348119
Beskrivning
ST depression
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beskrivning
U waves abnormal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0438169
Beskrivning
T wave inversion
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520888
Beskrivning
T wave peaked
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0239242
Beskrivning
T waves flat
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2215959
Beskrivning
T waves biphasic
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beskrivning
Notched T-waves
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347367
Beskrivning
Low QRS voltage
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2349945
Beskrivning
T-wave flattening/inversion
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520888
- UMLS CUI [2]
- C0429059
Beskrivning
Other depolarisation/repolarisation abnormality
Datatyp
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
Beskrivning
Comment other depolarisation/repolarisation
Datatyp
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
Beskrivning
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])