ID
38906
Beschrijving
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
Trefwoorden
Versies (3)
- 22-10-19 22-10-19 -
- 22-10-19 22-10-19 -
- 12-11-19 12-11-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
12 november 2019
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Type of Report
Alias
- UMLS CUI-1
- C0585733
Beschrijving
Randomisation
Alias
- UMLS CUI-1
- C0034656
Beschrijving
Serious adverse event Entry
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Hidden
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
SAE Diagnosis or Sign/Symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C3540840
Beschrijving
Hidden
Datatype
text
Alias
- UMLS CUI [1]
- C2826798
Beschrijving
Hidden
Datatype
text
Alias
- UMLS CUI [1]
- C1140263
Beschrijving
Hidden
Datatype
text
Alias
- UMLS CUI [1]
- C3898442
Beschrijving
Hidden
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
Adverse Event Start Date/Time
Datatype
partialDatetime
Alias
- UMLS CUI [1]
- C2826806
Beschrijving
if Recovered/Resolved (with or without sequelae) provide End Date and Time if Fatal, record Date and Time of Death
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
if applicable
Datatype
partialDatetime
Alias
- UMLS CUI [1]
- C2826793
Beschrijving
Serious Adverse Event Frequency
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439603
- UMLS CUI [1,2]
- C1519255
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
SAE Maximum Grade
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C1519255
Beschrijving
Action regarding Investigational Product
Datatype
text
Alias
- UMLS CUI [1]
- C1704758
Beschrijving
Subject withdrawal because of AE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0877248
Beschrijving
AE possibly caused by investigational product
Datatype
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C0877248
Beschrijving
[hidden]
Datatype
time
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Beschrijving
[hidden]
Datatype
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
Beschrijving
SAE caused by activities related to study participation
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C1547644
Beschrijving
Seriousness
Alias
- UMLS CUI-1
- C0566251
- UMLS CUI-2
- C1547644
Beschrijving
Adverse Event Results in death
Datatype
boolean
Alias
- UMLS CUI [1]
- C1320832
Beschrijving
Adverse event is life-threatening
Datatype
boolean
Alias
- UMLS CUI [1]
- C1517874
Beschrijving
adverse event requires hospitalisation or prolongation of hospitalisation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0745041
- UMLS CUI [2,2]
- C1519255
Beschrijving
Serious adverse event results in disability/incapacity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3176592
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0231170
- UMLS CUI [2,2]
- C1519255
Beschrijving
Serious adverse event: Congenital anomaly/birth defect
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Beschrijving
specify within general narrative comment
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1519255
Beschrijving
Liver injury and impaired liver function by ALT, Total bilirubin, INR
Datatype
boolean
Alias
- UMLS CUI [1]
- C0160390
- UMLS CUI [2]
- C0086565
- UMLS CUI [3]
- C0036828
- UMLS CUI [4]
- C0201913
- UMLS CUI [5]
- C0525032
Beschrijving
Relevant concomitant/treatment medications Entry
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0304229
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Beschrijving
(Trade Name preferred)
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Concomitant medication dose
Datatype
float
Alias
- UMLS CUI [1]
- C2826811
Beschrijving
Concomitant medication unit
Datatype
text
Alias
- UMLS CUI [1]
- C2826646
Beschrijving
Concomitant medication frequency
Datatype
text
Alias
- UMLS CUI [1]
- C2826654
Beschrijving
Concomitant medication route
Datatype
text
Alias
- UMLS CUI [1]
- C2826730
Beschrijving
Concomitant Medication Start Date
Datatype
partialDate
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
if no, specify End Date
Datatype
text
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Concomitant medication end date
Datatype
partialDate
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Concomitant Medication Primary Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826696
- UMLS CUI [1,2]
- C0205225
Beschrijving
Drug Type
Datatype
text
Alias
- UMLS CUI [1]
- C0457591
Beschrijving
Relevant Medical Conditions/Risk Factors
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beschrijving
Specific Condition
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschrijving
Date of onset
Datatype
partialDate
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
If no, specify date of last occurrence
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beschrijving
Date of last disease occurence
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beschrijving
Relevant Other Medical History / Risk Factors
Datatype
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
Beschrijving
Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beschrijving
Lab Test Name
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Test Date
Datatype
partialDate
Alias
- UMLS CUI [1]
- C2826247
Beschrijving
Laboratory Test Result
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Laboratory Test Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beschrijving
Normal Low Range
Datatype
text
Alias
- UMLS CUI [1]
- C1272773
Beschrijving
Normal High Range
Datatype
text
Alias
- UMLS CUI [1]
- C1299400
Beschrijving
Relevant other diagnostic laboratory results
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347946
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C0205394
Beschrijving
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Event recurrence after investigational product administered again
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C0304229
Beschrijving
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Beschrijving
Non clinical
Alias
- UMLS CUI-1
- C1320722
Beschrijving
[hidden]
Datatype
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
Beschrijving
[hidden]
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C2347796
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2985700
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C1516728
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C0013849
Similar models
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)
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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])