ID
38601
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 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.
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Trefwoorden
Versies (1)
- 26-10-19 26-10-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 oktober 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
Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol
- StudyEvent: ODM
Beschrijving
Liver Event Seriousness
Alias
- UMLS CUI-1
- C1710056
- UMLS CUI-2
- C0023884
Beschrijving
Notification Sent
Alias
- UMLS CUI-1
- C0422202
- UMLS CUI-2
- C0023884
Beschrijving
[read-only]
Datatype
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0013849
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1708968
Beschrijving
[read-only]
Datatype
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C0013849
- UMLS CUI [1,4]
- C1708968
Beschrijving
[read-only]
Datatype
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0013849
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C3899555
Beschrijving
[read-only]
Datatype
partialDatetime
Alias
- UMLS CUI [1,1]
- C1264639
- UMLS CUI [1,2]
- C0013849
- UMLS CUI [1,3]
- C0205435
- UMLS CUI [1,4]
- C3899555
Beschrijving
[read-only]
Datatype
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
Beschrijving
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
Beschrijving
It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
AST reached stopping criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
Total bilirubin reached stopping criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
Alkaline phosphatase reached stopping criteria
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
This item is conditional. Interruption may be removed if stopping/monitoring study only.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0202148
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
This item is conditional. Interruption may be removed if stopping/monitoring study only.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
Other liver chemistry result reached stopping criteria
Datatype
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
Beschrijving
Liver Events - Clinical
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0205210
Beschrijving
Age
Datatype
text
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
If yes, ensure Pregnancy Notification Form has been completed.
Datatype
text
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
If Yes, answer whether the results were normal
Datatype
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
Beschrijving
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.
Datatype
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
Beschrijving
If yes, complete Liver Biopsy form.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C1272695
Beschrijving
If yes, record on the appropriate Concomitant Medication form.
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0025125
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beschrijving
Recent fasting or significant dietary change
Datatype
text
Alias
- UMLS CUI [1,1]
- C3671772
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0332185
- UMLS CUI [2,2]
- C0015663
Beschrijving
[hidden] Item will be calculated by InForm.
Datatype
text
Alias
- UMLS CUI [1]
- C2826267
Beschrijving
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschrijving
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.
Datatype
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
Beschrijving
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.
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beschrijving
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.
Datatype
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beschrijving
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0023884
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschrijving
if applicable
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Beschrijving
if applicable
Datatype
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
Beschrijving
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
Beschrijving
Acute type A viral hepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C0276434
Beschrijving
Hepatitis B, Chronic
Datatype
integer
Alias
- UMLS CUI [1]
- C0524909
Beschrijving
Hepatitis C, Chronic
Datatype
integer
Alias
- UMLS CUI [1]
- C0524910
Beschrijving
Cytomegalovirus Hepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C0276252
Beschrijving
Infectious Mononucleosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0021345
Beschrijving
Herpes Simplex Hepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C1963747
Beschrijving
Alcoholic Liver Diseases
Datatype
integer
Alias
- UMLS CUI [1]
- C0023896
Beschrijving
Non-alcoholic Steatohepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C3241937
Beschrijving
Fatty Liver
Datatype
integer
Alias
- UMLS CUI [1]
- C0015695
Beschrijving
Hepatic Cirrhosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0023890
Beschrijving
Hemochromatosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0018995
Beschrijving
Autoimmune Hepatitis
Datatype
integer
Alias
- UMLS CUI [1]
- C0241910
Beschrijving
It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study.
Datatype
integer
Alias
- UMLS CUI [1]
- C0016977
Beschrijving
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0041755
Beschrijving
Other Liver Disease
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Other liver disease
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C2826302
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C3898442
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschrijving
Other Liver Disease Conditions - Status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Beschrijving
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschrijving
Drug Allergies
Datatype
integer
Alias
- UMLS CUI [1]
- C0013182
Beschrijving
Rheumatoid Arthritis
Datatype
integer
Alias
- UMLS CUI [1]
- C0003873
Beschrijving
Psoriasis
Datatype
integer
Alias
- UMLS CUI [1]
- C0033860
Beschrijving
Thyroid Disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0040128
Beschrijving
Inflammatory Bowel Disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0021390
Beschrijving
Lupus
Datatype
integer
Alias
- UMLS CUI [1]
- C0409974
Beschrijving
Sjogren's Syndrome
Datatype
integer
Alias
- UMLS CUI [1]
- C1527336
Beschrijving
Vitiligo
Datatype
integer
Alias
- UMLS CUI [1]
- C0042900
Beschrijving
Alcohol Intake at Onset of Liver Event
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0332162
- UMLS CUI-4
- C0877248
Beschrijving
If Yes, record the average number of units of alcohol consumed per week
Datatype
text
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
if applicable
Datatype
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
- UMLS CUI [1,3]
- C1510992
Beschrijving
[hidden] This item will be calculated by InForm.
Datatype
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])