ID

38649

Description

First Time in Human Study Using GSK2330672; ODM derived from: https://clinicaltrials.gov/show/NCT01416324

Link

https://clinicaltrials.gov/show/NCT01416324

Keywords

Versions (1)
  1. 10/29/19 10/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01416324

English

Eligibility Diabetes Mellitus, Type 2 NCT01416324

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy volunteer
Description

Healthy Volunteer

Data type

boolean

Alias
UMLS CUI [1]
C1708335
18-60 yrs of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
for subjects age 50 and above: negative fecal occult blood test within 3 months prior to expected start of dosing, and normal results from sigmoidoscopy or colonoscopy within 5 yrs prior to dosing.
Description

Age | Fecal occult blood test Negative | Sigmoidoscopy | Colonoscopy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0201811
UMLS CUI [2,2]
C1513916
UMLS CUI [3]
C0037075
UMLS CUI [4]
C0009378
if female, must be of non-childbearing potential
Description

Gender Childbearing Potential Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breastfeeding females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
positive hiv
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
positive hep b, or hep c within 3 months of screening
Description

Hepatitis B positive | Hepatitis C positive

Data type

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
positive drugs of abuse screening
Description

Drug abuse screening test Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0451130
UMLS CUI [1,2]
C1514241
triglycerides > 250 mg/dl
Description

Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202236
current or chronic history of liver disease
Description

Liver disease | Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0341439
any gastrointestinal or gastrointestinal related conditions that could affect fat or bile acid reabsorption
Description

Gastrointestinal condition Affecting Fat Reabsorption | Gastrointestinal condition Affecting Bile Acid Reabsorption

Data type

boolean

Alias
UMLS CUI [1,1]
C4062441
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0015677
UMLS CUI [1,4]
C3850140
UMLS CUI [2,1]
C4062441
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0005390
UMLS CUI [2,4]
C3850140
pancreatitis
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
colon cancer or 1st degree relative who has had colon cancer
Description

Colon Carcinoma | Colon Carcinoma First Degree Relative

Data type

boolean

Alias
UMLS CUI [1]
C0699790
UMLS CUI [2,1]
C0699790
UMLS CUI [2,2]
C1517194
abnormal lung function tests
Description

Lung function testing abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0476405
inability to perform lung function tests
Description

Pulmonary function tests Perform Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C1299582
unwilling to abstain from smoking, alcohol, caffeine, illicit drugs as directed by the site staff
Description

Refrain from Smoking Unwilling | Abstinence Alcohol consumption Unwilling | Abstinence Caffeine Unwilling | Abstinence Illicit Drugs Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C4086797
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C3843422
UMLS CUI [2,2]
C0001948
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C3843422
UMLS CUI [3,2]
C0006644
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C3843422
UMLS CUI [4,2]
C0086190
UMLS CUI [4,3]
C0558080
exposure to more than 4 new chemical entities in the 12 months prior to the first dosing day.
Description

Chemical exposure New Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0678803
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C1265611
where participation in the study would results in donation of more than approximately 550ml of blood in a 56-day period.
Description

Study Subject Participation Status Resulting in Blood Donation Amount

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0005794
UMLS CUI [1,4]
C1265611
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01416324

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteer
Item
healthy volunteer
boolean
C1708335 (UMLS CUI [1])
Age
Item
18-60 yrs of age
boolean
C0001779 (UMLS CUI [1])
Age | Fecal occult blood test Negative | Sigmoidoscopy | Colonoscopy
Item
for subjects age 50 and above: negative fecal occult blood test within 3 months prior to expected start of dosing, and normal results from sigmoidoscopy or colonoscopy within 5 yrs prior to dosing.
boolean
C0001779 (UMLS CUI [1])
C0201811 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0037075 (UMLS CUI [3])
C0009378 (UMLS CUI [4])
Gender Childbearing Potential Absent
Item
if female, must be of non-childbearing potential
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
positive hiv
boolean
C0019699 (UMLS CUI [1])
Hepatitis B positive | Hepatitis C positive
Item
positive hep b, or hep c within 3 months of screening
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
Drug abuse screening test Positive
Item
positive drugs of abuse screening
boolean
C0451130 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Triglycerides measurement
Item
triglycerides > 250 mg/dl
boolean
C0202236 (UMLS CUI [1])
Liver disease | Chronic liver disease
Item
current or chronic history of liver disease
boolean
C0023895 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
Gastrointestinal condition Affecting Fat Reabsorption | Gastrointestinal condition Affecting Bile Acid Reabsorption
Item
any gastrointestinal or gastrointestinal related conditions that could affect fat or bile acid reabsorption
boolean
C4062441 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0015677 (UMLS CUI [1,3])
C3850140 (UMLS CUI [1,4])
C4062441 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0005390 (UMLS CUI [2,3])
C3850140 (UMLS CUI [2,4])
Pancreatitis
Item
pancreatitis
boolean
C0030305 (UMLS CUI [1])
Colon Carcinoma | Colon Carcinoma First Degree Relative
Item
colon cancer or 1st degree relative who has had colon cancer
boolean
C0699790 (UMLS CUI [1])
C0699790 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
Lung function testing abnormal
Item
abnormal lung function tests
boolean
C0476405 (UMLS CUI [1])
Pulmonary function tests Perform Unable
Item
inability to perform lung function tests
boolean
C0024119 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Refrain from Smoking Unwilling | Abstinence Alcohol consumption Unwilling | Abstinence Caffeine Unwilling | Abstinence Illicit Drugs Unwilling
Item
unwilling to abstain from smoking, alcohol, caffeine, illicit drugs as directed by the site staff
boolean
C4086797 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C3843422 (UMLS CUI [2,1])
C0001948 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C3843422 (UMLS CUI [3,1])
C0006644 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C3843422 (UMLS CUI [4,1])
C0086190 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Chemical exposure New Quantity
Item
exposure to more than 4 new chemical entities in the 12 months prior to the first dosing day.
boolean
C0678803 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Study Subject Participation Status Resulting in Blood Donation Amount
Item
where participation in the study would results in donation of more than approximately 550ml of blood in a 56-day period.
boolean
C2348568 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0005794 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
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