ID

40943

Beschrijving

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

Trefwoorden

  1. 21-04-20 21-04-20 -
  2. 07-06-20 07-06-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

7 juni 2020

DOI

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Licentie

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

Pregnancy Information Follow-up 7-DF

Pregnancy Information
Beschrijving

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)
Beschrijving

Pregnancy Information

Datatype

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)
Datatype
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)

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