ID

41624

Description

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

Keywords

Versions (1)
  1. 11/29/20 11/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 29, 2020

DOI

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License

Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

English

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

1 forms  
Inform Screening
Description

Inform Screening

Alias
UMLS CUI-1
C1710477
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Inform Enrolment
Description

Inform Enrolment

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

Subject number

Data type

text

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

Date of visit/assessment

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

Date of visit/assessment

Data type

date

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

Subject group

Data type

text

Alias
UMLS CUI [1]
C1710223
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Description

Check all that apply

Data type

integer

Alias
UMLS CUI [1]
C3841890
Genotype
Description

Genotype

Alias
UMLS CUI-1
C0017431
Genotype
Description

Genotype

Data type

integer

Alias
UMLS CUI [1]
C0017431
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
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