ID

40951

Beschreibung

The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

Stichworte

Versionen (2)
  1. 24.04.20 24.04.20 -
  2. 07.06.20 07.06.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

7. Juni 2020

DOI

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Creative Commons BY-NC 4.0
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A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin

Englisch

Liver Events, Liver Event 2-DF

1 Formulare  
1. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Beschreibung

1. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?

Alias
UMLS CUI-1
C0023901
UMLS CUI-2
C1254595
UMLS CUI-3
C2746065
UMLS CUI-4
C0243161
UMLS CUI-5
C4688482
UMLS CUI-6
C2599718
UMLS CUI-7
C1550543
[1] ALT (alanine aminotransferase)
Beschreibung

alanine aminotransferase

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
[2] AST (aspartate aminotransferase)
Beschreibung

aspartate aminotransferase

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
[3] Total bilirubin
Beschreibung

Total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0201913
[4] Alkaline phosphatase
Beschreibung

Alkaline phosphatase

Datentyp

boolean

Alias
UMLS CUI [1]
C0201850
[5] 5' nucleotidase
Beschreibung

conditional

Datentyp

boolean

Alias
UMLS CUI [1]
C0202148
[6] Gammaglutamyltranspeptidase
Beschreibung

conditional

Datentyp

boolean

Alias
UMLS CUI [1]
C0202035
[OT] Other
Beschreibung

Other liver chemistry result

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0023901
UMLS CUI [1,4]
C0205394
Liver events
Beschreibung

Liver events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
2. Is the subject age 55 or older?
Beschreibung

subject age

Datentyp

boolean

Alias
UMLS CUI [1]
C0205847
UMLS CUI [2]
C0596728
UMLS CUI [3]
C0178694
3. If female, is the subject pregnant?
Beschreibung

If yes, ensure Pregnancy Notification Form has been completed.

Datentyp

text

Alias
UMLS CUI [1]
C0032961
4. Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Beschreibung

diagnostic imaging of liver or hepatobiliary system

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1711359
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C0023884
4. If diagnostic imaging tests were performed, were the results normal?
Beschreibung

If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1711359
UMLS CUI [1,2]
C0011923
UMLS CUI [1,3]
C1319347
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C0023884
UMLS CUI [2,3]
C1319347
5. Were any liver biopsies performed?
Beschreibung

If yes, complete Liver Biopsy form.

Datentyp

boolean

Alias
UMLS CUI [1]
C0193388
6. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Beschreibung

If yes, record on the appropriate Concomitant Medication form.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C1360419
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0936077
UMLS CUI [3,1]
C0681850
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0242295
UMLS CUI [4,1]
C0681850
UMLS CUI [4,2]
C0281875
7. Did the subject fast or undergo significant dietary change in the past week?
Beschreibung

dietary change

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C3671772
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0015663
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Ähnliche Modelle

Liver Events, Liver Event 2-DF

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
1. Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
C0023901 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
C2746065 (UMLS CUI-3)
C0243161 (UMLS CUI-4)
C4688482 (UMLS CUI-5)
C2599718 (UMLS CUI-6)
C1550543 (UMLS CUI-7)
alanine aminotransferase
Item
[1] ALT (alanine aminotransferase)
boolean
C0201836 (UMLS CUI [1])
aspartate aminotransferase
Item
[2] AST (aspartate aminotransferase)
boolean
C0201899 (UMLS CUI [1])
Total bilirubin
Item
[3] Total bilirubin
boolean
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
[4] Alkaline phosphatase
boolean
C0201850 (UMLS CUI [1])
5' nucleotidase
Item
[5] 5' nucleotidase
boolean
C0202148 (UMLS CUI [1])
Gammaglutamyltranspeptidase
Item
[6] Gammaglutamyltranspeptidase
boolean
C0202035 (UMLS CUI [1])
Other liver chemistry result
Item
[OT] Other
boolean
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0023901 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item Group
Liver events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
subject age
Item
2. Is the subject age 55 or older?
boolean
C0205847 (UMLS CUI [1])
C0596728 (UMLS CUI [2])
C0178694 (UMLS CUI [3])
Item
3. If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
subject pregnant
Code List
3. If female, is the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
diagnostic imaging of liver or hepatobiliary system
Item
4. Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C1711359 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
diagnostic imaging of liver or hepatobiliary system results
Item
4. If diagnostic imaging tests were performed, were the results normal?
boolean
C1711359 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C1319347 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C1319347 (UMLS CUI [2,3])
liver biopsies
Item
5. Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
complementary or alternative medicines, supplements, illicit drugs
Item
6. Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C0681850 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C1360419 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0936077 (UMLS CUI [2,3])
C0681850 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0242295 (UMLS CUI [3,3])
C0681850 (UMLS CUI [4,1])
C0281875 (UMLS CUI [4,2])
dietary change
Item
7. Did the subject fast or undergo significant dietary change in the past week?
boolean
C0681850 (UMLS CUI [1,1])
C3671772 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
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