ID

40942

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. 4/19/20 4/19/20 -
  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

Study Conclusion Follow-up 6

1 forms  
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of last contact
Description

Date of last contact

Data type

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Description

Withdrawal

Data type

integer

Alias
UMLS CUI [1]
C0422727
Date of decision to withdraw
Description

Date of decision to withdraw

Data type

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Primary reason for withdrawal
Description

Pre-defined sub-reasons are optional. The following primary reasons are optional: Lack of efficacy, Subject reached protocol-defined stopping criteria, Investigator discretion

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Primary reason for withdrawal: Investigator discretion, specify:
Description

Withdrawal reason Investigator discretion

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008961
UMLS CUI [1,4]
C0022423
UMLS CUI [1,5]
C2348235
Casebook ready for signature
Description

Data owner should check the box when data cleaning is complete

Data type

integer

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C2346576
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Similar models

Study Conclusion Follow-up 6

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
integer
C0422727 (UMLS CUI [1])
Withdrawal
Code List
Was the subject withdrawn from the study?
CL Item
No (1)
CL Item
Yes, complete details: (2)
Date of decision to withdraw
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Withdrawal reason
Code List
Primary reason for withdrawal
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event forms as appropriate) (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Investigator discretion, specify in the next question (Select this reason if none of the other primary reasons are appropriate) (7)
CL Item
Withdrew consent (8)
Withdrawal reason Investigator discretion
Item
Primary reason for withdrawal: Investigator discretion, specify:
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Casebook ready for signature
integer
C1706256 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Casebook ready for signature
Code List
Casebook ready for signature
CL Item
Yes (1)
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