ID

41624

Beskrivning

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Nyckelord

Versioner (1)
  1. 2020-11-29 2020-11-29 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

29 november 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

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

Tillbaka till modellkommentarer
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.

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

Engelsk

Screening - Inform Screening; Inform Enrolment; Date of visit/assessment; Genotype

1 Formulär  
Inform Screening
Beskrivning

Inform Screening

Alias
UMLS CUI-1
C1710477
Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Inform Enrolment
Beskrivning

Inform Enrolment

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C4041024
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Beskrivning

Date of visit/assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beskrivning

Date of visit/assessment

Datatyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Subject group
Beskrivning

Subject group

Datatyp

text

Alias
UMLS CUI [1]
C1710223
Demography
Beskrivning

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Sex

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beskrivning

Ethnicity

Datatyp

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Beskrivning

Check all that apply

Datatyp

integer

Alias
UMLS CUI [1]
C3841890
Genotype
Beskrivning

Genotype

Alias
UMLS CUI-1
C0017431
Genotype
Beskrivning

Genotype

Datatyp

integer

Alias
UMLS CUI [1]
C0017431
Tillbaka till toppen

Similar models

Screening - Inform Screening; Inform Enrolment; Date of visit/assessment; Genotype

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inform Screening
C1710477 (UMLS CUI-1)
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item Group
Inform Enrolment
C1552002 (UMLS CUI-1)
C4041024 (UMLS CUI-2)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item
Subject group
text
C1710223 (UMLS CUI [1])
Subject group
Code List
Subject group
CL Item
Part 1 (A1)
CL Item
Part 2 Cohort 1 (A2)
CL Item
Part 2 Cohort 2 (B)
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Laitno (2)
Item
Geographic ancestry
integer
C3841890 (UMLS CUI [1])
Geographic ancestry
Code List
Geographic ancestry
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan NAtive (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Hertiage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
Genotype
C0017431 (UMLS CUI-1)
Item
Genotype
integer
C0017431 (UMLS CUI [1])
Genotype
Code List
Genotype
CL Item
Ultra rapid metabolizers (1)
CL Item
Extensive metabolizers (2)
CL Item
Intermediate metabolizers (3)
CL Item
Poor metabolizers (4)
Tillbaka till toppen 

Kontakt

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

Fält markerade med * är obligatoriska.

Hjälp

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