ID
38906
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 should be filled in in case of a serious adverse event.
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Stichworte
Versionen (3)
- 22.10.19 22.10.19 -
- 22.10.19 22.10.19 -
- 12.11.19 12.11.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
12. November 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
Serious Adverse Event
- StudyEvent: ODM
Beschreibung
Type of Report
Alias
- UMLS CUI-1
- C0585733
Beschreibung
Randomisation
Alias
- UMLS CUI-1
- C0034656
Beschreibung
Serious adverse event Entry
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Hidden
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschreibung
SAE Diagnosis or Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C3540840
Beschreibung
Hidden
Datentyp
text
Alias
- UMLS CUI [1]
- C2826798
Beschreibung
Hidden
Datentyp
text
Alias
- UMLS CUI [1]
- C1140263
Beschreibung
Hidden
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
Hidden
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Adverse Event Start Date/Time
Datentyp
partialDatetime
Alias
- UMLS CUI [1]
- C2826806
Beschreibung
if Recovered/Resolved (with or without sequelae) provide End Date and Time if Fatal, record Date and Time of Death
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
if applicable
Datentyp
partialDatetime
Alias
- UMLS CUI [1]
- C2826793
Beschreibung
Serious Adverse Event Frequency
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439603
- UMLS CUI [1,2]
- C1519255
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C1710066
Beschreibung
SAE Maximum Grade
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C1519255
Beschreibung
Action regarding Investigational Product
Datentyp
text
Alias
- UMLS CUI [1]
- C1704758
Beschreibung
Subject withdrawal because of AE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0877248
Beschreibung
AE possibly caused by investigational product
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C0877248
Beschreibung
[hidden]
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Beschreibung
[hidden]
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1272706
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C0439659
- UMLS CUI [1,5]
- C1519255
Beschreibung
SAE caused by activities related to study participation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C1547644
Beschreibung
Seriousness
Alias
- UMLS CUI-1
- C0566251
- UMLS CUI-2
- C1547644
Beschreibung
Adverse Event Results in death
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1320832
Beschreibung
Adverse event is life-threatening
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1517874
Beschreibung
adverse event requires hospitalisation or prolongation of hospitalisation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0745041
- UMLS CUI [2,2]
- C1519255
Beschreibung
Serious adverse event results in disability/incapacity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3176592
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0231170
- UMLS CUI [2,2]
- C1519255
Beschreibung
Serious adverse event: Congenital anomaly/birth defect
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Beschreibung
specify within general narrative comment
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1519255
Beschreibung
Liver injury and impaired liver function by ALT, Total bilirubin, INR
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0160390
- UMLS CUI [2]
- C0086565
- UMLS CUI [3]
- C0036828
- UMLS CUI [4]
- C0201913
- UMLS CUI [5]
- C0525032
Beschreibung
Relevant concomitant/treatment medications Entry
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0304229
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Beschreibung
(Trade Name preferred)
Datentyp
text
Alias
- UMLS CUI [1]
- C2360065
Beschreibung
Concomitant medication dose
Datentyp
float
Alias
- UMLS CUI [1]
- C2826811
Beschreibung
Concomitant medication unit
Datentyp
text
Alias
- UMLS CUI [1]
- C2826646
Beschreibung
Concomitant medication frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C2826654
Beschreibung
Concomitant medication route
Datentyp
text
Alias
- UMLS CUI [1]
- C2826730
Beschreibung
Concomitant Medication Start Date
Datentyp
partialDate
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
if no, specify End Date
Datentyp
text
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Concomitant medication end date
Datentyp
partialDate
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Concomitant Medication Primary Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826696
- UMLS CUI [1,2]
- C0205225
Beschreibung
Drug Type
Datentyp
text
Alias
- UMLS CUI [1]
- C0457591
Beschreibung
Relevant Medical Conditions/Risk Factors
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beschreibung
Specific Condition
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschreibung
Date of onset
Datentyp
partialDate
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
If no, specify date of last occurrence
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beschreibung
Date of last disease occurence
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beschreibung
Relevant Other Medical History / Risk Factors
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347946
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0262926
- UMLS CUI [2,1]
- C2347946
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [2,3]
- C0035648
Beschreibung
Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beschreibung
Lab Test Name
Datentyp
text
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Test Date
Datentyp
partialDate
Alias
- UMLS CUI [1]
- C2826247
Beschreibung
Laboratory Test Result
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Laboratory Test Units
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beschreibung
Normal Low Range
Datentyp
text
Alias
- UMLS CUI [1]
- C1272773
Beschreibung
Normal High Range
Datentyp
text
Alias
- UMLS CUI [1]
- C1299400
Beschreibung
Relevant other diagnostic laboratory results
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2347946
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C0205394
Beschreibung
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beschreibung
Event recurrence after investigational product administered again
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C0304229
Beschreibung
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Beschreibung
Non clinical
Alias
- UMLS CUI-1
- C1320722
Beschreibung
[hidden]
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519246
- UMLS CUI [1,2]
- C0205257
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1511726
- UMLS CUI [1,5]
- C2347796
Beschreibung
[hidden]
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C2347796
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C2985700
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C1516728
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1]
- C0013849
Ähnliche Modelle
Serious Adverse Event
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2348184 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
C0231175 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
C1710066 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0566251 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0332149 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C0231170 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2])
C0036828 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
C0525032 (UMLS CUI [5])
C2347946 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C2347852 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
C0041281 (UMLS CUI-2)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0205225 (UMLS CUI [1,2])
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C2347946 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C2348184 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0205257 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C2347796 (UMLS CUI [1,5])
C2347796 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,2])