ID

40951

Description

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

Mots-clés

Versions (2)
  1. 24/04/2020 24/04/2020 -
  2. 07/06/2020 07/06/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

7 juin 2020

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Liver Events, Liver Event 2-DF

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

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)
Description

alanine aminotransferase

Type de données

boolean

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

aspartate aminotransferase

Type de données

boolean

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

Total bilirubin

Type de données

boolean

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

Alkaline phosphatase

Type de données

boolean

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

conditional

Type de données

boolean

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

conditional

Type de données

boolean

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

Other liver chemistry result

Type de données

boolean

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

Liver events

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

subject age

Type de données

boolean

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

If yes, ensure Pregnancy Notification Form has been completed.

Type de données

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)?
Description

diagnostic imaging of liver or hepatobiliary system

Type de données

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?
Description

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

Type de données

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?
Description

If yes, complete Liver Biopsy form.

Type de données

boolean

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

If yes, record on the appropriate Concomitant Medication form.

Type de données

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?
Description

dietary change

Type de données

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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Similar models

Liver Events, Liver Event 2-DF

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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