ID
38601
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 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 contains general information on any Liver Event happening during the study, including whether and when a pharmacokinetic sample has been obtained as well as information on the subject's general and liver-related medical conditions and alcohol intake. There are seperate forms for Imaging and Biopsy in case of a Liver Event.
Länk
https://clinicaltrials.gov/ct2/show/NCT01476046
Nyckelord
Versioner (1)
- 2019-10-26 2019-10-26 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
26 oktober 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol
- StudyEvent: ODM
Beskrivning
Liver Event Seriousness
Alias
- UMLS CUI-1
- C1710056
- UMLS CUI-2
- C0023884
Beskrivning
Notification Sent
Alias
- UMLS CUI-1
- C0422202
- UMLS CUI-2
- C0023884
Beskrivning
[read-only]
Datatyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0013849
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1708968
Beskrivning
[read-only]
Datatyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C0013849
- UMLS CUI [1,4]
- C1708968
Beskrivning
[read-only]
Datatyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0013849
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C3899555
Beskrivning
[read-only]
Datatyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0013849
- UMLS CUI [1,3]
- C0205435
- UMLS CUI [1,4]
- C3899555
Beskrivning
[read-only]
Datatyp
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C1710056
- UMLS CUI [1,3]
- C0023884
- UMLS CUI [1,4]
- C0443172
- UMLS CUI [1,5]
- C1518404
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0008000
- UMLS CUI-3
- C0304229
- UMLS CUI-4
- C2746065
- UMLS CUI-5
- C0243161
Beskrivning
It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
AST reached stopping criteria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
Total bilirubin reached stopping criteria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
Alkaline phosphatase reached stopping criteria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
This item is conditional. Interruption may be removed if stopping/monitoring study only.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0202148
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
This item is conditional. Interruption may be removed if stopping/monitoring study only.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
Other liver chemistry result reached stopping criteria
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0008000
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2746065
- UMLS CUI [1,6]
- C0243161
Beskrivning
Liver Events - Clinical
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0205210
Beskrivning
Age
Datatyp
text
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
If yes, ensure Pregnancy Notification Form has been completed.
Datatyp
text
Alias
- UMLS CUI [1]
- C0032961
Beskrivning
If Yes, answer whether the results were normal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0023884
- UMLS CUI [3]
- C0412534
- UMLS CUI [4]
- C0412620
- UMLS CUI [5]
- C0412693
- UMLS CUI [6]
- C0008310
Beskrivning
If applicable If No, record the details on the Imaging form. Please ensure the overall diagnosis indicated by imaging is captured on the Non-serious Adverse Event form or Serious Adverse Event form.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [1,3]
- C0456984
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C0456984
- UMLS CUI [2,3]
- C0023884
Beskrivning
If yes, complete Liver Biopsy form.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1272695
Beskrivning
If yes, record on the appropriate Concomitant Medication form.
Datatyp
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0025125
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beskrivning
Recent fasting or significant dietary change
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0015663
Beskrivning
[hidden] Item will be calculated by InForm.
Datatyp
text
Alias
- UMLS CUI [1]
- C2826267
Beskrivning
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beskrivning
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0439564
- UMLS CUI [1,5]
- C2347804
Beskrivning
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beskrivning
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beskrivning
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0023884
Beskrivning
An unscheduled PK sample must be obtained within obtained within 7 days of last dose. If yes, record date and time sample taken and date and time of last investigational product dose prior to PK sample
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beskrivning
if applicable
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Beskrivning
if applicable
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0945778
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C0005834
- UMLS CUI [1,5]
- C0031328
Beskrivning
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Beskrivning
Acute type A viral hepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0276434
Beskrivning
Hepatitis B, Chronic
Datatyp
integer
Alias
- UMLS CUI [1]
- C0524909
Beskrivning
Hepatitis C, Chronic
Datatyp
integer
Alias
- UMLS CUI [1]
- C0524910
Beskrivning
Cytomegalovirus Hepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0276252
Beskrivning
Infectious Mononucleosis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0021345
Beskrivning
Herpes Simplex Hepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C1963747
Beskrivning
Alcoholic Liver Diseases
Datatyp
integer
Alias
- UMLS CUI [1]
- C0023896
Beskrivning
Non-alcoholic Steatohepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C3241937
Beskrivning
Fatty Liver
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015695
Beskrivning
Hepatic Cirrhosis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0023890
Beskrivning
Hemochromatosis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018995
Beskrivning
Autoimmune Hepatitis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0241910
Beskrivning
It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0016977
Beskrivning
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0041755
Beskrivning
Other Liver Disease
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Other liver disease
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C2826302
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Other Liver Disease Conditions - Status
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beskrivning
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beskrivning
Drug Allergies
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013182
Beskrivning
Rheumatoid Arthritis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0003873
Beskrivning
Psoriasis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0033860
Beskrivning
Thyroid Disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0040128
Beskrivning
Inflammatory Bowel Disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0021390
Beskrivning
Lupus
Datatyp
integer
Alias
- UMLS CUI [1]
- C0409974
Beskrivning
Sjogren's Syndrome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1527336
Beskrivning
Vitiligo
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042900
Beskrivning
Alcohol Intake at Onset of Liver Event
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0332162
- UMLS CUI-4
- C0877248
Beskrivning
If Yes, record the average number of units of alcohol consumed per week
Datatyp
text
Alias
- UMLS CUI [1]
- C0001948
Beskrivning
if applicable
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
- UMLS CUI [1,3]
- C1510992
Beskrivning
[hidden] This item will be calculated by InForm.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0332307
Similar models
Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0013849 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,2])
C0013849 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,4])
C0013849 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C3899555 (UMLS CUI [1,4])
C0013849 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C3899555 (UMLS CUI [1,4])
C1710056 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])
C1518404 (UMLS CUI [1,5])
C0008000 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C2746065 (UMLS CUI-4)
C0243161 (UMLS CUI-5)
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
C0877248 (UMLS CUI-2)
C0205210 (UMLS CUI-3)
C1711359 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0412534 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0412693 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
C1711359 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
C1272695 (UMLS CUI [1,2])
C0025125 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
C0332185 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0031328 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
C0041755 (UMLS CUI-2)
C0041755 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0023884 (UMLS CUI-2)
C0332162 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C0560579 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])