ID
38912
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 a Holter ECG or Telemetry reading is abnormal.
Lien
https://clinicaltrials.gov/ct2/show/NCT01476046
Mots-clés
Versions (4)
- 25/10/2019 25/10/2019 -
- 12/11/2019 12/11/2019 - Sarah Riepenhausen
- 12/11/2019 12/11/2019 - Sarah Riepenhausen
- 20/09/2021 20/09/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
12 novembre 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
Unscheduled Holter/Telemetry Abnormalities
- StudyEvent: ODM
Description
Holter/Telemetry Abnormality
Alias
- UMLS CUI-1
- C0013801
- UMLS CUI-2
- C1832603
- UMLS CUI-3
- C0039451
Description
Test Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C0039593
Description
Test Start Date/Time
Type de données
datetime
Alias
- UMLS CUI [1]
- C3897500
Description
Test Stop Date/Time
Type de données
datetime
Alias
- UMLS CUI [1]
- C3899266
Description
Test method
Type de données
integer
Alias
- UMLS CUI [1]
- C0871511
Description
No abnormalities
Type de données
boolean
Alias
- UMLS CUI [1]
- C0522054
Description
Sinus bradycardia (50-59 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (heart rate 40-49 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (heart rate 30-39 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus bradycardia (heart rate <30 beats/min)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Description
Sinus pause
Type de données
boolean
Alias
- UMLS CUI [1]
- C1955864
Description
Sinus tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0039239
Description
Ectopic supraventricular beats
Type de données
boolean
Alias
- UMLS CUI [1]
- C0033036
Description
Ectopic supraventricular rhythm
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348376
Description
Wandering atrial pacemaker
Type de données
boolean
Alias
- UMLS CUI [1]
- C1321523
Description
Multifocal atrial tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0221158
Description
Non-sustained Supraventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0205374
Description
Sustained supraventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0443318
Description
Atrial flutter
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004239
Description
Atrial fibrillation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004238
Description
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C1287080
Description
Junctional tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0039235
Description
Ventricular premature depolarisation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0151636
Description
Ventricular couplets
Type de données
boolean
Alias
- UMLS CUI [1]
- C0429001
Description
Bigeminy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0262662
Description
Trigeminy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0428999
Description
Electrical alternans
Type de données
boolean
Alias
- UMLS CUI [1]
- C1142551
Description
R on T phenomenon
Type de données
boolean
Alias
- UMLS CUI [1]
- C0877658
Description
Ventricular fibrillation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0042510
Description
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0700363
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C1287080
Description
Non-sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0750194
Description
Sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0750197
Description
Wide QRS tachycardia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0344429
Description
Monomorphic non-sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750194
Description
Monomorphic sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750197
Description
Polymorphic non-sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750194
Description
Polymorphic sustained ventricular tachycardia
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
Description
Torsades de Pointes
Type de données
boolean
Alias
- UMLS CUI [1]
- C0040479
Description
Artificial Pacemaker
Type de données
boolean
Alias
- UMLS CUI [1]
- C0030163
Description
First degree AV block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085614
Description
Short PR interval
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520878
Description
Second degree AV block (Mobitz type 1)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264907
Description
Second degree AV block (Mobitz type 2)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0155700
Description
2: 1 AV block
Type de données
boolean
Alias
- UMLS CUI [1]
- C2346542
Description
Third degree AV block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
Left axis deviation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232297
Description
Right axis deviation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232296
Description
Incomplete right bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0262525
Description
Incomplete left bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0281878
Description
Right bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085615
Description
Left anterior hemiblock
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264912
Description
Left posterior hemiblock
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264913
Description
Left bundle branch block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0023211
Description
Bifascicular block
Type de données
boolean
Alias
- UMLS CUI [1]
- C0264914
Description
Non-specific intraventricular conduction delay
Type de données
boolean
Alias
- UMLS CUI [1]
- C3697597
Description
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Description
QTc prolongation by QTc time
Type de données
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Description
AV dissociation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004331
Description
Myocardial infarction, old
Type de données
boolean
Alias
- UMLS CUI [1]
- C0155668
Description
Myocardial infarction, Non Q-wave
Type de données
boolean
Alias
- UMLS CUI [1]
- C0542269
Description
Non-specific ST-T changes
Type de données
boolean
Alias
- UMLS CUI [1]
- C1112720
Description
J point elevation
Type de données
boolean
Alias
- UMLS CUI [1]
- C2346597
Description
ST elevation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520886
Description
ST segment abnormality
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348120
Description
ST depression
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520887
Description
U waves
Type de données
boolean
Alias
- UMLS CUI [1]
- C0232333
Description
T wave inversion
Type de données
boolean
Alias
- UMLS CUI [1]
- C0520888
Description
T wave peaked
Type de données
boolean
Alias
- UMLS CUI [1]
- C0239242
Description
T waves biphasic
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348639
Description
T waves flat
Type de données
boolean
Alias
- UMLS CUI [1]
- C2215959
Description
Notched T-waves
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347367
Description
Low QRS voltage
Type de données
boolean
Alias
- UMLS CUI [1]
- C2349945
Description
T wave abnormality
Type de données
boolean
Alias
- UMLS CUI [1]
- C0438167
Description
Please enter comment
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Description
Comment abnormal rhythm
Type de données
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Description
Other morphology
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Description
Comment other morphology
Type de données
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
Enter comment
Type de données
boolean
Alias
- UMLS CUI [1]
- C0340494
Description
Comment other conduction abnormality
Type de données
text
Alias
- UMLS CUI [1,1]
- C0340494
- UMLS CUI [1,2]
- C0947611
Description
Other myocardial infarction
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Description
Comment other myocardial infarction
Type de données
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
- UMLS CUI [1,3]
- C0947611
Description
Other depolarisation/repolarisation abnormality
Type de données
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
Type de données
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 abnormality/Cardiologist comments
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C0175906
- UMLS CUI [2,2]
- C0947611
Description
Other abnormality/Cardiologist comments
Type de données
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C3845569
- UMLS CUI [2,1]
- C0175906
- UMLS CUI [2,2]
- C0947611
Similar models
Unscheduled Holter/Telemetry Abnormalities
- StudyEvent: ODM
C1320722 (UMLS CUI-2)
C0013801 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
C1264639 (UMLS CUI [1,2])
C1832603 (UMLS CUI-2)
C0039451 (UMLS CUI-3)
C0039593 (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])
C0205374 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C0443318 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C1287080 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,2])
C1287080 (UMLS CUI [1,3])
C0750194 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
C0750194 (UMLS CUI [1,2])
C0750197 (UMLS CUI [1,2])
C0043202 (UMLS CUI [1,2])
C1963785 (UMLS CUI [2,1])
C0024054 (UMLS CUI [2,2])
C0489625 (UMLS CUI [2])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0199556 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0332437 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
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 [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C3845569 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])