ID

40952

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

Keywords

Versions (2)
  1. 4/24/20 4/24/20 -
  2. 6/7/20 6/7/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 7, 2020

DOI

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License

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

English

Investigational product (Liver), Liver Event 3-DF

1 forms  
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Description

If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C2709058
UMLS CUI-4
C4688482
1. Start Date Investigational Product [-99]
Description

Start Date Investigational Product treatment period

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C4688482
1. Start Date Investigational Product not applicable [-98]
Description

Start Date Investigational Product treatment period not applicable

Data type

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C4688482
UMLS CUI [1,3]
C1272460
2. End Date Investigational Product [-99]
Description

End Date Investigational Product treatment period

Data type

date

Alias
UMLS CUI [1,1]
C4688482
UMLS CUI [1,2]
C0806020
2. End Date Investigational Product not applicable [-98]
Description

End Date Investigational Product treatment period not applicable

Data type

boolean

Alias
UMLS CUI [1,1]
C4688482
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1272460
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.
Description

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.

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0231290
UMLS CUI-4
C4688482
3. Start Date Investigational Product [-99]
Description

Start Date Investigational Product

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C4688482
3. Start Date Investigational Product not applicable [-98]
Description

Start Date Investigational Product not applicable

Data type

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C4688482
UMLS CUI [1,3]
C1272460
4. End Date Investigational Product [-99]
Description

End Date Investigational Product

Data type

date

Alias
UMLS CUI [1,1]
C4688482
UMLS CUI [1,2]
C0806020
4. End Date Investigational Product not applicable [-98]
Description

End Date Investigational Product not applicable

Data type

boolean

Alias
UMLS CUI [1,1]
C4688482
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1272460
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Similar models

Investigational product (Liver), Liver Event 3-DF

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C2709058 (UMLS CUI-3)
C4688482 (UMLS CUI-4)
Start Date Investigational Product treatment period
Item
1. Start Date Investigational Product [-99]
date
C0808070 (UMLS CUI [1,1])
C4688482 (UMLS CUI [1,2])
Start Date Investigational Product treatment period not applicable
Item
1. Start Date Investigational Product not applicable [-98]
boolean
C0808070 (UMLS CUI [1,1])
C4688482 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
End Date Investigational Product treatment period
Item
2. End Date Investigational Product [-99]
date
C4688482 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Date Investigational Product treatment period not applicable
Item
2. End Date Investigational Product not applicable [-98]
boolean
C4688482 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
Item Group
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.
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0231290 (UMLS CUI-3)
C4688482 (UMLS CUI-4)
Start Date Investigational Product
Item
3. Start Date Investigational Product [-99]
date
C0808070 (UMLS CUI [1,1])
C4688482 (UMLS CUI [1,2])
Start Date Investigational Product not applicable
Item
3. Start Date Investigational Product not applicable [-98]
boolean
C0808070 (UMLS CUI [1,1])
C4688482 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
End Date Investigational Product
Item
4. End Date Investigational Product [-99]
date
C4688482 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Date Investigational Product not applicable
Item
4. End Date Investigational Product not applicable [-98]
boolean
C4688482 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
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