ID
42304
Beschrijving
Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases
Trefwoorden
Versies (1)
- 26-05-21 26-05-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 mei 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812
Liver Assessment; Liver Biopsy; Liver Events; Liver Imaging
- StudyEvent: ODM
Beschrijving
Liver Events Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-3
- C0877248
- UMLS CUI-5
- C0220825
Beschrijving
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232741
- UMLS CUI [2]
- C0008000
- UMLS CUI [3,1]
- C0304229
- UMLS CUI [3,2]
- C2746065
- UMLS CUI [3,3]
- C0243161
Beschrijving
Liver Biopsy
Alias
- UMLS CUI-1
- C0193388
Beschrijving
Date of liver biopsy
Datatype
date
Alias
- UMLS CUI [1,1]
- C0193388
- UMLS CUI [1,2]
- C0011008
Beschrijving
Approximate size of liver biopsy
Datatype
float
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C1299482
- UMLS CUI [1,2]
- C0193388
Beschrijving
Check all that apply
Datatype
text
Alias
- UMLS CUI [1]
- C1546485
Beschrijving
Specify other Final Diagnosis
Datatype
text
Alias
- UMLS CUI [1,1]
- C1546485
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348235
Beschrijving
Check all that apply
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
Beschrijving
Specify other Liver Architecture
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0935919
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C2348235
Beschrijving
Check all that apply
Datatype
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0678257
Beschrijving
Specify other Liver or Hepatocytes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0678257
- UMLS CUI [1,3]
- C0205394
Beschrijving
Check all that apply
Datatype
text
Alias
- UMLS CUI [1]
- C0227525
- UMLS CUI [2]
- C0042219
- UMLS CUI [3]
- C1512693
Beschrijving
Specify other Liver Cell or Hepatocyte Inclusions or Vacuoles
Datatype
text
Alias
- UMLS CUI [1]
- C0227525
- UMLS CUI [2]
- C0042219
- UMLS CUI [3]
- C1512693
- UMLS CUI [4]
- C0205394
- UMLS CUI [5]
- C2348235
Beschrijving
Check all that apply
Datatype
text
Alias
- UMLS CUI [1]
- C0227525
- UMLS CUI [2,1]
- C1849376
- UMLS CUI [2,2]
- C0193388
Beschrijving
Specify other Hepatocyte or Liver Cell Nuclear Abnormalities
Datatype
text
Alias
- UMLS CUI [1]
- C0227525
- UMLS CUI [2,1]
- C1849376
- UMLS CUI [2,2]
- C0193388
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C2348235
Beschrijving
Check all that apply
Datatype
text
Alias
- UMLS CUI [1]
- C0205417
- UMLS CUI [2]
- C1400896
Beschrijving
Specify other Liver or Lobular Infiltrates
Datatype
text
Alias
- UMLS CUI [1]
- C0205417
- UMLS CUI [2]
- C1400896
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C2348235
Beschrijving
Check all that apply
Datatype
text
Alias
- UMLS CUI [1]
- C3854488
Beschrijving
Specify other Portal Tract Inflammation
Datatype
text
Alias
- UMLS CUI [1]
- C3854488
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
Check all that apply
Datatype
text
Alias
- UMLS CUI [1]
- C0005400
Beschrijving
Specify other Bile Ducts
Datatype
text
Alias
- UMLS CUI [1]
- C0005400
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
Check all that apply
Datatype
text
Alias
- UMLS CUI [1]
- C0032718
Beschrijving
Specify other Portal Veins
Datatype
text
Alias
- UMLS CUI [1]
- C0032718
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
J. Liver Infections
Datatype
text
Alias
- UMLS CUI [1]
- C1112211
Beschrijving
Specify other Liver Infection
Datatype
text
Alias
- UMLS CUI [1]
- C1112211
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
K. Parasites or Ova
Datatype
text
Alias
- UMLS CUI [1]
- C0030498
- UMLS CUI [2]
- C0555117
Beschrijving
Specify other Parasites or Ova
Datatype
text
Alias
- UMLS CUI [1]
- C0030498
- UMLS CUI [2]
- C0555117
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C2348235
Beschrijving
L. Histologic Staining or Additional Studies Obtained
Datatype
text
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C1524062
Beschrijving
Specify other Histologic Staining or Additional Studies Obtained
Datatype
text
Alias
- UMLS CUI [1,1]
- C0487602
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C1524062
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschrijving
Check all that apply
Datatype
text
Alias
- UMLS CUI [1]
- C0023884
- UMLS CUI [2]
- C0022885
- UMLS CUI [3,1]
- C2746065
- UMLS CUI [3,2]
- C0243161
Beschrijving
If the liver event occurred during treatment period record start date of investigational product for that treatment period.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [2]
- C0087111
- UMLS CUI [3]
- C0347984
- UMLS CUI [4,1]
- C0304229
- UMLS CUI [4,2]
- C0808070
Beschrijving
If the liver event occurred during treatment period record stop date of investigational product for that treatment period.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [2]
- C0087111
- UMLS CUI [3]
- C0347984
- UMLS CUI [4,1]
- C0304229
- UMLS CUI [4,2]
- C0806020
Beschrijving
If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C0687676
- UMLS CUI [3]
- C0304229
- UMLS CUI [4]
- C0808070
Beschrijving
If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C0687676
- UMLS CUI [3]
- C0304229
- UMLS CUI [4]
- C0806020
Beschrijving
Is the subject age 55 or older?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
If female, ist the subject pregnant?
Datatype
text
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011923
- UMLS CUI [2]
- C1711359
- UMLS CUI [3]
- C0023884
- UMLS CUI [4]
- C1456803
- UMLS CUI [5]
- C0040405
- UMLS CUI [6]
- C0436427
- UMLS CUI [7]
- C0024485
- UMLS CUI [8]
- C0008310
Beschrijving
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0011923
Beschrijving
If Yes, complete Liver Biopsy form.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0193388
Beschrijving
If Yes, record on the appropriate Concomitant Medication form.
Datatype
boolean
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0281875
Beschrijving
Did the subject fast or undergo significant dietary change in the past week?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Beschrijving
An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1/2;).
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschrijving
If Yes, date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschrijving
If Yes, date and time of last investigational product dose prior to PK sample
Datatype
datetime
Alias
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C1762893
- UMLS CUI [3,1]
- C0304229
- UMLS CUI [3,2]
- C0946444
Beschrijving
Sample Identifier Label
Datatype
text
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0600091
Beschrijving
Sample Number
Datatype
text
Alias
- UMLS CUI [1]
- C1299222
Beschrijving
Alcohol Intake
Alias
- UMLS CUI-1
- C0001948
Beschrijving
1 unit of alcohol in UK = 1 measure of spirits, 1/2 pint beer, 1 small glass of wine (125ml) If the subject does not drink enter '0'.
Datatype
integer
Maateenheden
- units/week
Alias
- UMLS CUI [1]
- C0001948
- UMLS CUI [2]
- C0560579
Beschrijving
Liver Disease Medical Conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0262926
Beschrijving
Check only one response for each condition
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschrijving
Condition Status
Datatype
integer
Alias
- UMLS CUI [1]
- C3176928
Beschrijving
Drug Related Liver Disease Conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beschrijving
Other Liver Disease Conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beschrijving
Other Medical Conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beschrijving
Check only one response for each condition
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschrijving
Condition Status
Datatype
integer
Alias
- UMLS CUI [1]
- C3176928
Beschrijving
Liver Imaging
Alias
- UMLS CUI-1
- C2711860
Beschrijving
Date of hepatic or liver imaging test
Datatype
date
Alias
- UMLS CUI [1]
- C2711860
- UMLS CUI [2]
- C0011008
Beschrijving
Check one. If more than one imaging test was performed, complete a separate form for each test).
Datatype
integer
Alias
- UMLS CUI [1]
- C2711860
- UMLS CUI [2]
- C1275506
Beschrijving
Specify other method for imaging
Datatype
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C1275506
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
Check one.
Datatype
text
Alias
- UMLS CUI [1]
- C0806487
Beschrijving
Specify other image quality
Datatype
text
Alias
- UMLS CUI [1]
- C0806487
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
Check one.
Datatype
text
Alias
- UMLS CUI [1]
- C0426688
Beschrijving
Specify other liver size
Datatype
text
Alias
- UMLS CUI [1,1]
- C0426688
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348235
Beschrijving
Check one.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0679033
- UMLS CUI [1,2]
- C0023884
Beschrijving
Specify other liver texture
Datatype
text
Alias
- UMLS CUI [1,1]
- C1285481
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348235
Beschrijving
Check one.
Datatype
text
Alias
- UMLS CUI [1]
- C0015695
- UMLS CUI [2]
- C0205219
- UMLS CUI [3]
- C1517526
- UMLS CUI [4]
- C0332448
Beschrijving
Specify other diffuse and/or geographic fatty infiltrate
Datatype
text
Alias
- UMLS CUI [1]
- C0015695
- UMLS CUI [2]
- C0205219
- UMLS CUI [3]
- C1517526
- UMLS CUI [4]
- C0205394
- UMLS CUI [5]
- C2348235
Beschrijving
Check one
Datatype
text
Alias
- UMLS CUI [1]
- C0003962
Beschrijving
Specify other ascites
Datatype
text
Alias
- UMLS CUI [1,1]
- C0003962
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348235
Beschrijving
Check all that apply.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
Beschrijving
Specify other focal hepatic lesion
Datatype
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Beschrijving
Check all that apply.
Datatype
text
Alias
- UMLS CUI [1,1]
- C3842395
- UMLS CUI [1,2]
- C0221198
Beschrijving
Specify other gallstones or gallbladder lesions.
Datatype
text
Alias
- UMLS CUI [1]
- C3842395
- UMLS CUI [2]
- C0221198
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C2348235
Beschrijving
Check all that apply.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
Beschrijving
Specify other biliary duct lesion
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
Check all that apply.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0019155
- UMLS CUI [2,2]
- C1704258
Beschrijving
Specify other portal/hepatic vein abnormalities.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0032718
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [3]
- C0205394
- UMLS CUI [4]
- C2348235
Similar models
Liver Assessment; Liver Biopsy; Liver Events; Liver Imaging
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0877248 (UMLS CUI-3)
C0220825 (UMLS CUI-5)
C0008000 (UMLS CUI [2])
C0304229 (UMLS CUI [3,1])
C2746065 (UMLS CUI [3,2])
C0243161 (UMLS CUI [3,3])
C0011008 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0935919 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0042219 (UMLS CUI [2])
C1512693 (UMLS CUI [3])
C0042219 (UMLS CUI [2])
C1512693 (UMLS CUI [3])
C0205394 (UMLS CUI [4])
C2348235 (UMLS CUI [5])
C1849376 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
C1849376 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
C1400896 (UMLS CUI [2])
C1400896 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0555117 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
C0023884 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0022885 (UMLS CUI [2])
C2746065 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
C0347984 (UMLS CUI [3])
C0304229 (UMLS CUI [4,1])
C0808070 (UMLS CUI [4,2])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
C0347984 (UMLS CUI [3])
C0304229 (UMLS CUI [4,1])
C0806020 (UMLS CUI [4,2])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
C0808070 (UMLS CUI [4])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
C0806020 (UMLS CUI [4])
C1711359 (UMLS CUI [2])
C0023884 (UMLS CUI [3])
C1456803 (UMLS CUI [4])
C0040405 (UMLS CUI [5])
C0436427 (UMLS CUI [6])
C0024485 (UMLS CUI [7])
C0008310 (UMLS CUI [8])
C0011923 (UMLS CUI [1,2])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0281875 (UMLS CUI [5])
C3671772 (UMLS CUI [2])
C0031328 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C1762893 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0946444 (UMLS CUI [3,2])
C0600091 (UMLS CUI [1,2])
C0560579 (UMLS CUI [2])
C0262926 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0277579 (UMLS CUI-2)
C0277579 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C1275506 (UMLS CUI [2])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205219 (UMLS CUI [2])
C1517526 (UMLS CUI [3])
C0332448 (UMLS CUI [4])
C0205219 (UMLS CUI [2])
C1517526 (UMLS CUI [3])
C0205394 (UMLS CUI [4])
C2348235 (UMLS CUI [5])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205234 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C1704258 (UMLS CUI [1,2])
C0019155 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])