ID
40944
Beschreibung
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
Stichworte
Versionen (2)
- 21.04.20 21.04.20 -
- 07.06.20 07.06.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
7. Juni 2020
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
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
Logs and repeats Logs/Repeats 1
- StudyEvent: ODM
Beschreibung
Adverse event/concomitant medication/repeat assessment check questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0205341
- UMLS CUI-4
- C0220825
Beschreibung
concomitant medications
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0681850
- UMLS CUI [1,4]
- C0347984
- UMLS CUI [1,5]
- C0008972
Beschreibung
non-serious adverse events
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0681850
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008972
Beschreibung
serious adverse events
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0681850
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008972
Beschreibung
abnormal ECG measurements
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008972
- UMLS CUI [1,4]
- C1832603
- UMLS CUI [1,5]
- C2985739
Beschreibung
repeat haematology, clinical chemistry or urinalysis samples
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0205341
- UMLS CUI [2,1]
- C0018941
- UMLS CUI [2,2]
- C0200345
- UMLS CUI [2,3]
- C0205341
- UMLS CUI [3,1]
- C0042014
- UMLS CUI [3,2]
- C0200345
- UMLS CUI [3,3]
- C0205341
Beschreibung
repeat ECGs
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0205341
Beschreibung
repeat vital signs
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beschreibung
PK: pharmacokinetic
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0031327
- UMLS CUI [1,3]
- C0205341
Beschreibung
PD: Pharmacodynamic
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0851347
- UMLS CUI [1,3]
- C0200345
Ähnliche Modelle
Logs and repeats Logs/Repeats 1
- StudyEvent: ODM
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0013227 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008972 (UMLS CUI [1,5])
C0681850 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,4])
C0681850 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008972 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C1832603 (UMLS CUI [1,4])
C2985739 (UMLS CUI [1,5])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0042014 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
C0205341 (UMLS CUI [3,3])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0851347 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])