ID
38912
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 a Holter ECG or Telemetry reading is abnormal.
Länk
https://clinicaltrials.gov/ct2/show/NCT01476046
Nyckelord
Versioner (4)
- 2019-10-25 2019-10-25 -
- 2019-11-12 2019-11-12 - Sarah Riepenhausen
- 2019-11-12 2019-11-12 - Sarah Riepenhausen
- 2021-09-20 2021-09-20 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
12 november 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
Unscheduled Holter/Telemetry Abnormalities
- StudyEvent: ODM
Beskrivning
Holter/Telemetry Abnormality
Alias
- UMLS CUI-1
- C0013801
- UMLS CUI-2
- C1832603
- UMLS CUI-3
- C0039451
Beskrivning
Test Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C0039593
Beskrivning
Test Start Date/Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C3897500
Beskrivning
Test Stop Date/Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C3899266
Beskrivning
Test method
Datatyp
integer
Alias
- UMLS CUI [1]
- C0871511
Beskrivning
No abnormalities
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0522054
Beskrivning
Sinus bradycardia (50-59 beats/min)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0085610
- UMLS CUI [1,2]
- C0018810
Beskrivning
Sinus bradycardia (heart rate 40-49 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
Non-sustained Supraventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0205374
Beskrivning
Sustained supraventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C0443318
Beskrivning
Atrial flutter
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004239
Beskrivning
Atrial fibrillation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0004238
Beskrivning
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232208
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C1287080
Beskrivning
Junctional tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0039235
Beskrivning
Ventricular premature depolarisation
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
Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0700363
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [1,3]
- C1287080
Beskrivning
Non-sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750194
Beskrivning
Sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750197
Beskrivning
Wide QRS tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0344429
Beskrivning
Monomorphic non-sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750194
Beskrivning
Monomorphic sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344431
- UMLS CUI [1,2]
- C0750197
Beskrivning
Polymorphic non-sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750194
Beskrivning
Polymorphic sustained ventricular tachycardia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0344432
- UMLS CUI [1,2]
- C0750197
Beskrivning
Torsades de Pointes
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0040479
Beskrivning
Artificial Pacemaker
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0030163
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
Left anterior hemiblock
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0264912
Beskrivning
Left posterior hemiblock
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
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
Myocardial infarction, old
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0155668
Beskrivning
Myocardial infarction, Non Q-wave
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0542269
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 segment abnormality
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348120
Beskrivning
ST depression
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0520887
Beskrivning
U waves
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0232333
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 biphasic
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348639
Beskrivning
T waves flat
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2215959
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 abnormality
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0438167
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
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
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
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
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 abnormality/Cardiologist comments
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C0175906
- UMLS CUI [2,2]
- C0947611
Beskrivning
Other abnormality/Cardiologist comments
Datatyp
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])