ID

40935

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

Versions (4)
  1. 4/18/20 4/18/20 -
  2. 4/18/20 4/18/20 -
  3. 4/18/20 4/18/20 -
  4. 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

Demography Screen 2

1 forms  
  1. StudyEvent: ODM
    1. Demography Screen 2
Demography
Description

Demography

Alias
UMLS CUI-1
C1704791
Date of birth
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

If female, please record child-bearnig potential in the following item.

Data type

text

Alias
UMLS CUI [1]
C0079399
Child-bearing potential
Description

Only in female patients.

Data type

integer

Alias
UMLS CUI [1]
C3831118
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Description

Geographic ancestry

Alias
UMLS CUI-1
C3841890
Geographic ancestry: African American/African Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0085756
UMLS CUI [3]
C0027567
Geographic ancestry: American Indian or Alaskan Native
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C1515945
Geographic ancestry: Asian - Central/South Asian Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0238696
UMLS CUI [3]
C1519427
Geographic ancestry: Asian - East Asian Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C4540996
Geographic ancestry: Asian - Japanese Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C1556094
Geographic ancestry: Asian - South East Asian Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0238697
Geographic ancestry: Native Hawaiian or Other Pacific Islander
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C1513907
Geographic ancestry: White - Arabic/North African Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0238604
UMLS CUI [3]
C2698217
Geographic ancestry: White - White/Caucasian/European Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C3841890
UMLS CUI [2]
C0043157
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Similar models

Demography Screen 2

1 forms
  1. StudyEvent: ODM
    1. Demography Screen 2
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demography
C1704791 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Child-bearing potential
integer
C3831118 (UMLS CUI [1])
Child-bearing potential
Code List
Child-bearing potential
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Geographic ancestry
C3841890 (UMLS CUI-1)
Geographic ancestry: African American/African Heritage
Item
Geographic ancestry: African American/African Heritage
boolean
C3841890 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
C0027567 (UMLS CUI [3])
Geographic ancestry: American Indian or Alaskan Native
Item
Geographic ancestry: American Indian or Alaskan Native
boolean
C3841890 (UMLS CUI [1])
C1515945 (UMLS CUI [2])
Geographic ancestry: Asian - Central/South Asian Heritage
Item
Geographic ancestry: Asian - Central/South Asian Heritage
boolean
C3841890 (UMLS CUI [1])
C0238696 (UMLS CUI [2])
C1519427 (UMLS CUI [3])
Geographic ancestry: Asian - East Asian Heritage
Item
Geographic ancestry: Asian - East Asian Heritage
boolean
C3841890 (UMLS CUI [1])
C4540996 (UMLS CUI [2])
Geographic ancestry: Asian - Japanese Heritage
Item
Geographic ancestry: Asian - Japanese Heritage
boolean
C3841890 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
Geographic ancestry: Asian - South East Asian Heritage
Item
Geographic ancestry: Asian - South East Asian Heritage
boolean
C3841890 (UMLS CUI [1])
C0238697 (UMLS CUI [2])
Geographic ancestry: Native Hawaiian or Other Pacific Islander
Item
Geographic ancestry: Native Hawaiian or Other Pacific Islander
boolean
C3841890 (UMLS CUI [1])
C1513907 (UMLS CUI [2])
Geographic ancestry: White - Arabic/North African Heritage
Item
Geographic ancestry: White - Arabic/North African Heritage
boolean
C3841890 (UMLS CUI [1])
C0238604 (UMLS CUI [2])
C2698217 (UMLS CUI [3])
Geographic ancestry: White - White/Caucasian/European Heritage
Item
Geographic ancestry: White - White/Caucasian/European Heritage
boolean
C3841890 (UMLS CUI [1])
C0043157 (UMLS CUI [2])
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