ID

40943

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

  1. 4/21/20 4/21/20 -
  2. 6/7/20 6/7/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 7, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

Pregnancy Information Follow-up 7-DF

Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study? (If Yes, complete the paper Pregnancy Notification form)
Description

Pregnancy Information

Data type

integer

Alias
UMLS CUI [1,1]
C0036911
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C3828490

Similar models

Pregnancy Information Follow-up 7-DF

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner of the male subject become pregnant during the study? (If Yes, complete the paper Pregnancy Notification form)
integer
C0036911 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])
Code List
Did a female partner of the male subject become pregnant during the study? (If Yes, complete the paper Pregnancy Notification form)
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not Applicable (check if female partner not of childbearing potential or no female partner) (3)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial