ID

32923

Descripción

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

Palabras clave

Versiones (1)
  1. 20/11/18 20/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

20 de noviembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

Inglés

Liver Event Form: General Data

1 formularios  
Administrative data
Descripción

Administrative data

Study Name
Descripción

Study Name

Tipo de datos

text

Site
Descripción

Site

Tipo de datos

text

Subject
Descripción

Subject

Tipo de datos

text

Visit Name
Descripción

Visit Name

Tipo de datos

text

DCI Name/Shortname
Descripción

DCI Name/Shortname

Tipo de datos

text

Status
Descripción

Status

Tipo de datos

text

Doc#
Descripción

Doc#

Tipo de datos

integer

Visit #
Descripción

Visit #

Tipo de datos

float

Liver Events Assessment
Descripción

Liver Events Assessment

Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
Descripción

If YES, stop investigational product, complete date on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following test: -Blood sample for PK analysis, obtained within three half-lives (21 days) of last dose -Hepatitis A -Hepatitis B -Hepatitis C -Hepatitis E -Cytomegalovirus IgM antibody -EBV or if unavailabel, obtain heteropile antibody or monospot testing -CPK -LDH -Bilirubin fractionation, if bilirubin >=1.5xULN

Tipo de datos

boolean

Liver Event Description
Descripción

Liver Event Description

Date of assessment
Descripción

Date of assessment

Tipo de datos

date

AE/SAE reference number
Descripción

AE/SAE reference number

Tipo de datos

text

Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Descripción

check all that apply

Tipo de datos

text

Other, specify
Descripción

Other, specify

Tipo de datos

text

Is the subject age 55 or older?
Descripción

Is the subject age 55 or older?

Tipo de datos

boolean

If female, is the subject pregnant?
Descripción

If YES, ensure Pregnancy Notification Form has been completed.

Tipo de datos

text

Were any diagnostic tests of the liver or hepatobiliary system performed?
Descripción

Were any diagnostic tests of the liver or hepatobiliary system performed?

Tipo de datos

boolean

If Yes, were the results normal?
Descripción

If Yes, complete Liver Biopsy Form

Tipo de datos

boolean

Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Descripción

If Yes, record on the appropriate Concomitant Medication form

Tipo de datos

boolean

Did the subject fast or undergo significant dietary change in the past week?
Descripción

Did the subject fast or undergo significant dietary change in the past week?

Tipo de datos

boolean

Was a pharmacokinetic blood sample obtained?
Descripción

An unscheduled PK blood sample must be obtained within three half-lives

Tipo de datos

boolean

If Yes, date of sample taken
Descripción

If Yes, date of sample taken

Tipo de datos

date

If Yes, time of sample taken
Descripción

If Yes, time of sample taken

Tipo de datos

time

If Yes, date of last investigational product dose prior to PK sample
Descripción

If Yes, date of last investigational product dose prior to PK sample

Tipo de datos

date

If Yes, time of last investigational product dose prior to PK sample
Descripción

If Yes, time of last investigational product dose prior to PK sample

Tipo de datos

time

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Similar models

Liver Event Form: General Data

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
Study Name
Item
Study Name
text
Site
Item
Site
text
Subject
Item
Subject
text
Visit Name
Item
Visit Name
text
DCI Name/Shortname
Item
DCI Name/Shortname
text
Status
Item
Status
text
Doc#
Item
Doc#
integer
Visit #
Item
Visit #
float
Item Group
Liver Events Assessment
Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
boolean
Item Group
Liver Event Description
Date of assessment
Item
Date of assessment
date
AE/SAE reference number
Item
AE/SAE reference number
text
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
text
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspartate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Other (4)
Other, specify
Item
Other, specify
text
Is the subject age 55 or older?
Item
Is the subject age 55 or older?
boolean
Item
If female, is the subject pregnant?
text
If female, is the subject pregnant?
Code List
If female, is the subject pregnant?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Were any diagnostic tests of the liver or hepatobiliary system performed?
Item
Were any diagnostic tests of the liver or hepatobiliary system performed?
boolean
If Yes, were the results normal?
Item
If Yes, were the results normal?
boolean
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
Did the subject fast or undergo significant dietary change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
If Yes, date of sample taken
Item
If Yes, date of sample taken
date
If Yes, time of sample taken
Item
If Yes, time of sample taken
time
If Yes, date of last investigational product dose prior to PK sample
Item
If Yes, date of last investigational product dose prior to PK sample
date
If Yes, time of last investigational product dose prior to PK sample
Item
If Yes, time of last investigational product dose prior to PK sample
time
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