ID
33376
Beskrivning
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the liver events form. It has to be filled in if a liver event occurs during study (including screening and study visit).
Länk
https://clinicaltrials.gov/ct2/show/NCT00599612
Nyckelord
Versioner (2)
- 2018-12-04 2018-12-04 -
- 2018-12-07 2018-12-07 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
7 december 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612
Liver events
- StudyEvent: ODM
Beskrivning
Liver events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Beskrivning
day month year
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Time period to the onset of ALT ≥ 2xUpper Limit Normal (ULN). Note: Although stopping criteria is ALT 3x ULN, GSK are interested in capturing ALT≥2x ULNto assess the probability of drug relatedness of liver event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0201836
Beskrivning
AST
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0201899
Beskrivning
Total bilirubin
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0201913
Beskrivning
Alkaline phosphatase
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0201850
Beskrivning
Other
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205394
Beskrivning
Liver events assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Beskrivning
If Yes, stop investigational product, complete date stopped on lnvestigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following tests: PK blood sample within 24 hours of last dose (or 3x the investigational product half-life or t1/2). Hepatitis A: Hepatitis A lgM antibody. Hepatitis B: Hepatitis B surface antigen and Hepatitis B Core Antibody (/gM). Hepatitis C: Hepatitis C RNA. Hepatitis E /gM antibody (if subject resides or hastravelled in past 3 months outside the USA or Canada). Cytomegalovirus lgM antibody (CMV) EBV (Epstein Barr viral capsid antigen /gM antibody) or if unavailable, obtain heterophile antibody or monospot testing. CPK (serum creatine phosphokinase) LDH (factate dehydrogenase) Bilirubin fractionation, if bilirubin ≥ 1,5xULN The following are only needed when ALT ≥ 3xULN and bilirubin ≥ 1,5xULN (>35% direct): Anti-nuclear antibody Anti-smooth muscle antibody Type 1 anti-liver kidney microsomal antibodies (if available) Liver Imaging (ultrasound, magnetic resonance, or computerised tomography
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C1254595
- UMLS CUI [1,4]
- C2746065
- UMLS CUI [1,5]
- C0243161
Beskrivning
Treatment periods applicable to the onset of ALT≥2x ULN
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C1948053
- UMLS CUI-3
- C0201836
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. Tick for each period/event
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
Beskrivning
Start Date lnvestigational Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beskrivning
End Date lnvestigational Product
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beskrivning
Liver events, Diagnositics
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0430022
Beskrivning
Age of subject
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
Performance of diagnostic imaging tests of the liver or hepatobiliary system (liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C1711359
- UMLS CUI [3,1]
- C0023884
- UMLS CUI [3,2]
- C0041618
- UMLS CUI [4]
- C0040405
- UMLS CUI [5]
- C0024485
- UMLS CUI [6]
- C0008310
- UMLS CUI [7]
- C0205394
Beskrivning
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0086143
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205307
Beskrivning
If Yes, complete Liver Biopsy form.
Datatyp
text
Alias
- UMLS CUI [1]
- C0193388
Beskrivning
If Yes, record on the appropriate Concomitant Medication form.
Datatyp
text
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C0002346
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beskrivning
Dietary Change, Fasting
Datatyp
text
Alias
- UMLS CUI [1]
- C3671772
- UMLS CUI [2]
- C0015663
Beskrivning
An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1!2).
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005834
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C1517741
- UMLS CUI [2,2]
- C0304229
- UMLS CUI [2,3]
- C0678766
- UMLS CUI [2,4]
- C0332152
- UMLS CUI [2,5]
- C0031327
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [2,1]
- C1517741
- UMLS CUI [2,2]
- C0304229
- UMLS CUI [2,3]
- C0678766
- UMLS CUI [2,4]
- C0332152
- UMLS CUI [2,5]
- C0031327
Beskrivning
Sample Identifier Label
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0600091
Beskrivning
Sample Number
Datatyp
text
Alias
- UMLS CUI [1]
- C1299222
Beskrivning
Alcohol intake
Alias
- UMLS CUI-1
- C0001948
Beskrivning
LIVER DISEASE MEDICAL CONDITIONS
Alias
- UMLS CUI-1
- C0023895
Beskrivning
Tick only one response for each condition
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beskrivning
Definitions: CURRENT MEDICAL CONDITIONS Conditionsfrom which the subject is currentlysuffering, regardlessof how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator's opinion it is likely to recur during the study. PAST MEDICAL CONDITIONS Conditions from which the subject has sufferedin the past, but are no longer present. A past condition may have stoppedas recently as the day prior to being assessed. NO MEDICAL CONDITION No current or past condition.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beskrivning
DRUG RELATED LIVER DISEASE CONDITIONS (All drugs including lnvestigational Product)
Beskrivning
OTHER LIVER DISEASE CONDITIONS
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beskrivning
Other liver disease
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
Beskrivning
Definitions: CURRENT MEDICAL CONDITIONS Conditionsfrom which the subject is currentlysuffering, regardlessof how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator's opinion it is likely to recur during the study. PAST MEDICAL CONDITIONS Conditions from which the subject has sufferedin the past, but are no longer present. A past condition may have stoppedas recently as the day prior to being assessed.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beskrivning
OTHER MEDICAL CONDITIONS
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beskrivning
Disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0012634
Beskrivning
Definitions: CURRENT MEDICAL CONDITIONS Conditionsfrom which the subject is currentlysuffering, regardlessof how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator's opinion it is likely to recur during the study. PAST MEDICAL CONDITIONS Conditions from which the subject has sufferedin the past, but are no longer present. A past condition may have stoppedas recently as the day prior to being assessed. NO MEDICAL CONDITION No current or past condition.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Similar models
Liver events
- StudyEvent: ODM
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0008000 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,5])
C1948053 (UMLS CUI-2)
C0201836 (UMLS CUI-3)
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0023884 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C0023884 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
C0205394 (UMLS CUI [7])
C0456984 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0002346 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
C0015663 (UMLS CUI [2])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C0031327 (UMLS CUI [2,5])
C0040223 (UMLS CUI [1,2])
C1517741 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C0031327 (UMLS CUI [2,5])
C0600091 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0277579 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])