ID
38906
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 should be filled in in case of a serious adverse event.
Länk
https://clinicaltrials.gov/ct2/show/NCT01476046
Nyckelord
Versioner (3)
- 2019-10-22 2019-10-22 -
- 2019-10-22 2019-10-22 -
- 2019-11-12 2019-11-12 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
12 november 2019
DOI
För en begäran logga in.
Licens
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
Beskrivning
Type of Report
Alias
- UMLS CUI-1
- C0585733
Beskrivning
Randomisation
Alias
- UMLS CUI-1
- C0034656
Beskrivning
Serious adverse event Entry
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Hidden
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
SAE Diagnosis or Sign/Symptom
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C3540840
Beskrivning
Hidden
Datatyp
text
Alias
- UMLS CUI [1]
- C2826798
Beskrivning
Hidden
Datatyp
text
Alias
- UMLS CUI [1]
- C1140263
Beskrivning
Hidden
Datatyp
text
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
Hidden
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Adverse Event Start Date/Time
Datatyp
partialDatetime
Alias
- UMLS CUI [1]
- C2826806
Beskrivning
if Recovered/Resolved (with or without sequelae) provide End Date and Time if Fatal, record Date and Time of Death
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
if applicable
Datatyp
partialDatetime
Alias
- UMLS CUI [1]
- C2826793
Beskrivning
Serious Adverse Event Frequency
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439603
- UMLS CUI [1,2]
- C1519255
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
SAE Maximum Grade
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C1519255
Beskrivning
Action regarding Investigational Product
Datatyp
text
Alias
- UMLS CUI [1]
- C1704758
Beskrivning
Subject withdrawal because of AE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0877248
Beskrivning
AE possibly caused by investigational product
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C0877248
Beskrivning
[hidden]
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Beskrivning
[hidden]
Datatyp
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
Beskrivning
SAE caused by activities related to study participation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C1547644
Beskrivning
Seriousness
Alias
- UMLS CUI-1
- C0566251
- UMLS CUI-2
- C1547644
Beskrivning
Adverse Event Results in death
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1320832
Beskrivning
Adverse event is life-threatening
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1517874
Beskrivning
adverse event requires hospitalisation or prolongation of hospitalisation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0745041
- UMLS CUI [2,2]
- C1519255
Beskrivning
Serious adverse event results in disability/incapacity
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3176592
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0231170
- UMLS CUI [2,2]
- C1519255
Beskrivning
Serious adverse event: Congenital anomaly/birth defect
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Beskrivning
specify within general narrative comment
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1519255
Beskrivning
Liver injury and impaired liver function by ALT, Total bilirubin, INR
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0160390
- UMLS CUI [2]
- C0086565
- UMLS CUI [3]
- C0036828
- UMLS CUI [4]
- C0201913
- UMLS CUI [5]
- C0525032
Beskrivning
Relevant concomitant/treatment medications Entry
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0304229
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1]
- C2360065
Beskrivning
Concomitant medication dose
Datatyp
float
Alias
- UMLS CUI [1]
- C2826811
Beskrivning
Concomitant medication unit
Datatyp
text
Alias
- UMLS CUI [1]
- C2826646
Beskrivning
Concomitant medication frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C2826654
Beskrivning
Concomitant medication route
Datatyp
text
Alias
- UMLS CUI [1]
- C2826730
Beskrivning
Concomitant Medication Start Date
Datatyp
partialDate
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
if no, specify End Date
Datatyp
text
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Concomitant medication end date
Datatyp
partialDate
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Concomitant Medication Primary Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2826696
- UMLS CUI [1,2]
- C0205225
Beskrivning
Drug Type
Datatyp
text
Alias
- UMLS CUI [1]
- C0457591
Beskrivning
Relevant Medical Conditions/Risk Factors
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beskrivning
Specific Condition
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beskrivning
Date of onset
Datatyp
partialDate
Alias
- UMLS CUI [1]
- C0574845
Beskrivning
If no, specify date of last occurrence
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Beskrivning
Date of last disease occurence
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beskrivning
Relevant Other Medical History / Risk Factors
Datatyp
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
Beskrivning
Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beskrivning
Lab Test Name
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Test Date
Datatyp
partialDate
Alias
- UMLS CUI [1]
- C2826247
Beskrivning
Laboratory Test Result
Datatyp
text
Alias
- UMLS CUI [1]
- C0587081
Beskrivning
Laboratory Test Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beskrivning
Normal Low Range
Datatyp
text
Alias
- UMLS CUI [1]
- C1272773
Beskrivning
Normal High Range
Datatyp
text
Alias
- UMLS CUI [1]
- C1299400
Beskrivning
Relevant other diagnostic laboratory results
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347946
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C0205394
Beskrivning
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beskrivning
Event recurrence after investigational product administered again
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C0304229
Beskrivning
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Beskrivning
Non clinical
Alias
- UMLS CUI-1
- C1320722
Beskrivning
[hidden]
Datatyp
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
Beskrivning
[hidden]
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C2347796
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2985700
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C1516728
Beskrivning
[hidden]
Datatyp
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)
(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])