ID
38594
Beschreibung
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.
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Stichworte
Versionen (4)
- 25.10.19 25.10.19 -
- 12.11.19 12.11.19 - Sarah Riepenhausen
- 12.11.19 12.11.19 - Sarah Riepenhausen
- 20.09.21 20.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
25. Oktober 2019
DOI
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Lizenz
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
Beschreibung
Holter/Telemetry Abnormality
Alias
- UMLS CUI-1
- C0013801
- UMLS CUI-2
- C1832603
- UMLS CUI-3
- C0039451
Beschreibung
Test Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C0039593
Beschreibung
Test Start Date/Time
Datentyp
datetime
Alias
- UMLS CUI [1]
- C3897500
Beschreibung
Test Stop Date/Time
Datentyp
datetime
Alias
- UMLS CUI [1]
- C3899266
Beschreibung
Test method
Datentyp
integer
Alias
- UMLS CUI [1]
- C0871511
Beschreibung
No abnormalities
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0522054
Beschreibung
Sinus bradycardia (50-59 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
Sinus bradycardia (heart rate 40-49 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
Sinus bradycardia (heart rate 30-39 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
Sinus bradycardia (heart rate <30 beats/min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beschreibung
Sinus pause
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1955864
Beschreibung
Sinus tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039239
Beschreibung
Ectopic supraventricular beats
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0033036
Beschreibung
Ectopic supraventricular rhythm
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348376
Beschreibung
Wandering atrial pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321523
Beschreibung
Multifocal atrial tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0221158
Beschreibung
Non-sustained Supraventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0205374
Beschreibung
Sustained supraventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0443318
Beschreibung
Atrial flutter
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beschreibung
Atrial fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beschreibung
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C1287080
Beschreibung
Junctional tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0039235
Beschreibung
Ventricular premature depolarisation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151636
Beschreibung
Ventricular couplets
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0429001
Beschreibung
Bigeminy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262662
Beschreibung
Trigeminy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0428999
Beschreibung
Electrical alternans
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1142551
Beschreibung
R on T phenomenon
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877658
Beschreibung
Ventricular fibrillation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0042510
Beschreibung
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0700363
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C1287080
Beschreibung
Non-sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beschreibung
Sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beschreibung
Wide QRS tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0344429
Beschreibung
Monomorphic non-sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750194
Beschreibung
Monomorphic sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750197
Beschreibung
Polymorphic non-sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750194
Beschreibung
Polymorphic sustained ventricular tachycardia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
Beschreibung
Torsades de Pointes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beschreibung
Artificial Pacemaker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030163
Beschreibung
First degree AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085614
Beschreibung
Short PR interval
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520878
Beschreibung
Second degree AV block (Mobitz type 1)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264907
Beschreibung
Second degree AV block (Mobitz type 2)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155700
Beschreibung
2: 1 AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346542
Beschreibung
Third degree AV block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0151517
Beschreibung
Left axis deviation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232297
Beschreibung
Right axis deviation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232296
Beschreibung
Incomplete right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262525
Beschreibung
Incomplete left bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0281878
Beschreibung
Right bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085615
Beschreibung
Left anterior hemiblock
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264912
Beschreibung
Left posterior hemiblock
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264913
Beschreibung
Left bundle branch block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023211
Beschreibung
Bifascicular block
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0264914
Beschreibung
Non-specific intraventricular conduction delay
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3697597
Beschreibung
Accessory pathway in Wolff-Parkinson White/Lown-Ganong-Levine Syndrome
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1963785
- UMLS CUI [1,2]
- C0043202
- UMLS CUI [2,1]
- C1963785
- UMLS CUI [2,2]
- C0024054
Beschreibung
QTc prolongation by QTc time
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0855333
- UMLS CUI [2]
- C0489625
Beschreibung
AV dissociation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0004331
Beschreibung
Myocardial infarction, old
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beschreibung
Myocardial infarction, Non Q-wave
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0542269
Beschreibung
Non-specific ST-T changes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1112720
Beschreibung
J point elevation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2346597
Beschreibung
ST elevation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520886
Beschreibung
ST segment abnormality
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348120
Beschreibung
ST depression
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beschreibung
U waves
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0232333
Beschreibung
T wave inversion
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0520888
Beschreibung
T wave peaked
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0239242
Beschreibung
T waves biphasic
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beschreibung
T waves flat
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2215959
Beschreibung
Notched T-waves
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347367
Beschreibung
Low QRS voltage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349945
Beschreibung
T wave abnormality
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0438167
Beschreibung
Please enter comment
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beschreibung
Comment abnormal rhythm
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0205161
Beschreibung
Other morphology
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beschreibung
Comment other morphology
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschreibung
Enter comment
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0340494
Beschreibung
Comment other conduction abnormality
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0340494
- UMLS CUI [1,2]
- C0947611
Beschreibung
Other myocardial infarction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
Beschreibung
Comment other myocardial infarction
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0027051
- UMLS CUI [1,3]
- C0947611
Beschreibung
Other depolarisation/repolarisation abnormality
Datentyp
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
Beschreibung
Comment other depolarisation/repolarisation
Datentyp
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
Beschreibung
Other abnormality/Cardiologist comments
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C0175906
- UMLS CUI [2,2]
- C0947611
Beschreibung
Other abnormality/Cardiologist comments
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C3845569
- UMLS CUI [2,1]
- C0175906
- UMLS CUI [2,2]
- C0947611
Ähnliche Modelle
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])