ID

32523

Beskrivning

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Nyckelord

  1. 2018-10-01 2018-10-01 -
  2. 2018-11-06 2018-11-06 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 november 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229

  1. StudyEvent: ODM
    1. Day 28
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beskrivning

Date in time

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Weight
Beskrivning

Body Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood Pressure (sitting) - Systolic
Beskrivning

Systolic Pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (sitting) - Diastolic
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate (sitting)
Beskrivning

Heart rate

Datatyp

text

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Immunogenicity testing, Blood
Beskrivning

Immunogenicity testing, Blood

Alias
UMLS CUI-1
C4054739
UMLS CUI-2
C0005767
Planned Relative Time
Beskrivning

Immunogenicity Study; Blood; relative time

Datatyp

text

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
Date Sample Taken
Beskrivning

Immunogenicity Study; Blood; Sampling; Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beskrivning

Immunogenicity Study; Blood; Sampling; Time

Datatyp

time

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
Sample Number
Beskrivning

Immunogenicity Study; Blood; Sample identification number

Datatyp

integer

Alias
UMLS CUI [1,1]
C4054739
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222
Pharmacokinetics; Blood
Beskrivning

Pharmacokinetics; Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Beskrivning

Pharmacokinetic aspects; Blood; relative time

Datatyp

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
Date Sample Taken
Beskrivning

Pharmacokinetic aspects; Blood; Sampling; Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Beskrivning

Pharmacokinetic aspects; Blood; Sampling; Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0040223
Sample Number
Beskrivning

Pharmacokinetic aspects; Blood; Sample identification number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C1299222

Similar models

  1. StudyEvent: ODM
    1. Day 28
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date in time
Item
Date
date
C0011008 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Pressure
Item
Blood Pressure (sitting) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure (sitting) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate (sitting)
text
C0018810 (UMLS CUI [1])
Item Group
Immunogenicity testing, Blood
C4054739 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Immunogenicity Study; Blood; relative time
Item
Planned Relative Time
text
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Immunogenicity Study; Blood; Sampling; Date in time
Item
Date Sample Taken
date
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Immunogenicity Study; Blood; Sampling; Time
Item
Actual Time
time
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Immunogenicity Study; Blood; Sample identification number
Item
Sample Number
integer
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Item Group
Pharmacokinetics; Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Pharmacokinetic aspects; Blood; relative time
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; Sampling; Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacokinetic aspects; Blood; Sampling; Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Pharmacokinetic aspects; Blood; Sample identification number
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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