ID

32696

Beschrijving

A Study to Compare the Safety and Drug Levels in Blood When Using Various Forms of GSK189075 Given to Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00559884

Link

https://clinicaltrials.gov/show/NCT00559884

Trefwoorden

  1. 12-11-18 12-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 november 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Mellitus NCT00559884

Eligibility Type 2 Diabetes Mellitus NCT00559884

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
are a healthy, non-smoking adult, 18 to 55 years old.
Beschrijving

Healthy adult | Non-smoker | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0686750
UMLS CUI [2]
C0337672
UMLS CUI [3]
C0001779
are not overly thin or overly heavy for your height.
Beschrijving

Normal body weight

Datatype

boolean

Alias
UMLS CUI [1]
C1285592
are a female who is unable to have children, or is willing to use birth control throughout the study.
Beschrijving

Female infertility | Gender Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0021361
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
are willing and able to follow all study-related instructions provided by the site staff. - are willing to provide signed consent.
Beschrijving

Protocol Compliance | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
are a pregnant or a nursing female.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
Beschrijving

Heart Disease | Liver disease | Kidney Disease | Hematological Disease | Brain Disease | Disease Other

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0006111
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205394
have had certain infections within 4 weeks before the expected the first dose of study drug.
Beschrijving

Communicable Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
have hiv or hepatitis, or have alcohol in your system at the screening visit.
Beschrijving

HIV Infection | Hepatitis | Alcohol intake Screening

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019158
UMLS CUI [3,1]
C0001948
UMLS CUI [3,2]
C1710477
have a history of alcohol abuse.
Beschrijving

Alcohol abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0085762
have been in another research study in the last month or have taken certain medications in the 2 weeks before study drug would be taken.
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
have laboratory tests that are outside the normal range.
Beschrijving

Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0438215

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00559884

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Healthy adult | Non-smoker | Age
Item
are a healthy, non-smoking adult, 18 to 55 years old.
boolean
C0686750 (UMLS CUI [1])
C0337672 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Normal body weight
Item
are not overly thin or overly heavy for your height.
boolean
C1285592 (UMLS CUI [1])
Female infertility | Gender Contraceptive methods
Item
are a female who is unable to have children, or is willing to use birth control throughout the study.
boolean
C0021361 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Protocol Compliance | Informed Consent
Item
are willing and able to follow all study-related instructions provided by the site staff. - are willing to provide signed consent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
are a pregnant or a nursing female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease | Liver disease | Kidney Disease | Hematological Disease | Brain Disease | Disease Other
Item
have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
boolean
C0018799 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0006111 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0205394 (UMLS CUI [6,2])
Communicable Diseases
Item
have had certain infections within 4 weeks before the expected the first dose of study drug.
boolean
C0009450 (UMLS CUI [1])
HIV Infection | Hepatitis | Alcohol intake Screening
Item
have hiv or hepatitis, or have alcohol in your system at the screening visit.
boolean
C0019693 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0001948 (UMLS CUI [3,1])
C1710477 (UMLS CUI [3,2])
Alcohol abuse
Item
have a history of alcohol abuse.
boolean
C0085762 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
have been in another research study in the last month or have taken certain medications in the 2 weeks before study drug would be taken.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Laboratory test result abnormal
Item
have laboratory tests that are outside the normal range.
boolean
C0438215 (UMLS CUI [1])

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