ID

41300

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 Mellitis 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

  1. 8/11/20 8/11/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 11, 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

Meal B/L/D V10 2-DF

  1. StudyEvent: ODM
    1. Meal B/L/D V10 2-DF
Breakfast
Description

Breakfast

Alias
UMLS CUI-1
C2698559
Start Date/Time
Description

Start Date/Time

Data type

datetime

Alias
UMLS CUI [1]
C3897500
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Has the totality of the meal been ingested?
Description

Has the totality of the meal been ingested?

Data type

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
If No, % of meal consumed
Description

If No, % of meal consumed

Data type

text

Alias
UMLS CUI [1]
C3468056
Lunch
Description

Lunch

Alias
UMLS CUI-1
C2697949
Start Date/Time
Description

Start Date/Time

Data type

datetime

Alias
UMLS CUI [1]
C3897500
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Has the totality of the meal been ingested?
Description

Has the totality of the meal been ingested?

Data type

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
If No, % of meal consumed
Description

If No, % of meal consumed

Data type

text

Alias
UMLS CUI [1]
C3468056
Dinner
Description

Dinner

Alias
UMLS CUI-1
C4048877
Start Date/Time
Description

Start Date/Time

Data type

datetime

Alias
UMLS CUI [1]
C3897500
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
Has the totality of the meal been ingested?
Description

Has the totality of the meal been ingested?

Data type

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0205197
If No, % of meal consumed
Description

If No, % of meal consumed

Data type

text

Alias
UMLS CUI [1]
C3468056

Similar models

Meal B/L/D V10 2-DF

  1. StudyEvent: ODM
    1. Meal B/L/D V10 2-DF
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breakfast
C2698559 (UMLS CUI-1)
Start Date/Time
Item
Start Date/Time
datetime
C3897500 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Has the totality of the meal been ingested?
Item
Has the totality of the meal been ingested?
boolean
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
If No, % of meal consumed
text
C3468056 (UMLS CUI [1])
Code List
If No, % of meal consumed
CL Item
0% (0%)
CL Item
1-25% (1-25%)
CL Item
26-50% (26-50%)
CL Item
51-75% (51-75%)
CL Item
76-100% (76-100%)
Item Group
Lunch
C2697949 (UMLS CUI-1)
Start Date/Time
Item
Start Date/Time
datetime
C3897500 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Has the totality of the meal been ingested?
Item
Has the totality of the meal been ingested?
boolean
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
If No, % of meal consumed
text
C3468056 (UMLS CUI [1])
Code List
If No, % of meal consumed
CL Item
0% (0%)
CL Item
1-25% (1-25%)
CL Item
26-50% (26-50%)
CL Item
51-75% (51-75%)
CL Item
76-100% (76-100%)
Item Group
Dinner
C4048877 (UMLS CUI-1)
Start Date/Time
Item
Start Date/Time
datetime
C3897500 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
Has the totality of the meal been ingested?
Item
Has the totality of the meal been ingested?
boolean
C1998602 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
If No, % of meal consumed
text
C3468056 (UMLS CUI [1])
Code List
If No, % of meal consumed
CL Item
0% (0%)
CL Item
1-25% (1-25%)
CL Item
26-50% (26-50%)
CL Item
51-75% (51-75%)
CL Item
76-100% (76-100%)

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