ID
38906
Descripción
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
Palabras clave
Versiones (3)
- 22/10/19 22/10/19 -
- 22/10/19 22/10/19 -
- 12/11/19 12/11/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
12 de noviembre de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Type of Report
Alias
- UMLS CUI-1
- C0585733
Descripción
Randomisation
Alias
- UMLS CUI-1
- C0034656
Descripción
Serious adverse event Entry
Alias
- UMLS CUI-1
- C1519255
Descripción
Hidden
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Descripción
SAE Diagnosis or Sign/Symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C3540840
Descripción
Hidden
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826798
Descripción
Hidden
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1140263
Descripción
Hidden
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3898442
Descripción
Hidden
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Descripción
Adverse Event Start Date/Time
Tipo de datos
partialDatetime
Alias
- UMLS CUI [1]
- C2826806
Descripción
if Recovered/Resolved (with or without sequelae) provide End Date and Time if Fatal, record Date and Time of Death
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1705586
Descripción
if applicable
Tipo de datos
partialDatetime
Alias
- UMLS CUI [1]
- C2826793
Descripción
Serious Adverse Event Frequency
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439603
- UMLS CUI [1,2]
- C1519255
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1710066
Descripción
SAE Maximum Grade
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0441799
- UMLS CUI [1,2]
- C1710066
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C1519255
Descripción
Action regarding Investigational Product
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1704758
Descripción
Subject withdrawal because of AE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0877248
Descripción
AE possibly caused by investigational product
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332149
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C0877248
Descripción
[hidden]
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Descripción
[hidden]
Tipo de datos
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
Descripción
SAE caused by activities related to study participation
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0441655
- UMLS CUI [1,4]
- C2348568
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1547644
Descripción
Seriousness
Alias
- UMLS CUI-1
- C0566251
- UMLS CUI-2
- C1547644
Descripción
Adverse Event Results in death
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1320832
Descripción
Adverse event is life-threatening
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1517874
Descripción
adverse event requires hospitalisation or prolongation of hospitalisation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0745041
- UMLS CUI [2,2]
- C1519255
Descripción
Serious adverse event results in disability/incapacity
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3176592
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0231170
- UMLS CUI [2,2]
- C1519255
Descripción
Serious adverse event: Congenital anomaly/birth defect
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Descripción
specify within general narrative comment
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1519255
Descripción
Liver injury and impaired liver function by ALT, Total bilirubin, INR
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0160390
- UMLS CUI [2]
- C0086565
- UMLS CUI [3]
- C0036828
- UMLS CUI [4]
- C0201913
- UMLS CUI [5]
- C0525032
Descripción
Relevant concomitant/treatment medications Entry
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C2347946
- UMLS CUI-3
- C0304229
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Descripción
(Trade Name preferred)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2360065
Descripción
Concomitant medication dose
Tipo de datos
float
Alias
- UMLS CUI [1]
- C2826811
Descripción
Concomitant medication unit
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826646
Descripción
Concomitant medication frequency
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826654
Descripción
Concomitant medication route
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826730
Descripción
Concomitant Medication Start Date
Tipo de datos
partialDate
Alias
- UMLS CUI [1]
- C2826734
Descripción
if no, specify End Date
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826666
Descripción
Concomitant medication end date
Tipo de datos
partialDate
Alias
- UMLS CUI [1]
- C2826744
Descripción
Concomitant Medication Primary Indication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2826696
- UMLS CUI [1,2]
- C0205225
Descripción
Drug Type
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0457591
Descripción
Relevant Medical Conditions/Risk Factors
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Descripción
Specific Condition
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Descripción
Date of onset
Tipo de datos
partialDate
Alias
- UMLS CUI [1]
- C0574845
Descripción
If no, specify date of last occurrence
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
Descripción
Date of last disease occurence
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Descripción
Relevant Other Medical History / Risk Factors
Tipo de datos
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
Descripción
Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C2347946
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Descripción
Lab Test Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0022885
Descripción
Test Date
Tipo de datos
partialDate
Alias
- UMLS CUI [1]
- C2826247
Descripción
Laboratory Test Result
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0587081
Descripción
Laboratory Test Units
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Descripción
Normal Low Range
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1272773
Descripción
Normal High Range
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1299400
Descripción
Relevant other diagnostic laboratory results
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2347946
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [1,3]
- C0205394
Descripción
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Descripción
Event recurrence after investigational product administered again
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C0304229
Descripción
General narrative comments
Alias
- UMLS CUI-1
- C0947611
Descripción
Non clinical
Alias
- UMLS CUI-1
- C1320722
Descripción
[hidden]
Tipo de datos
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
Descripción
[hidden]
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C2347796
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2985700
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C1516728
Descripción
[hidden]
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013849
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(Comment:en)
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C0041281 (UMLS CUI-2)
(Comment:en)
(Comment:en)
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(Comment:en)
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C0205225 (UMLS CUI [1,2])
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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])
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C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
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C1519255 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C2347796 (UMLS CUI [1,5])
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