ID

33735

Description

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment; ODM derived from: https://clinicaltrials.gov/show/NCT02016911

Link

https://clinicaltrials.gov/show/NCT02016911

Keywords

Versions (1)
  1. 12/21/18 12/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02016911

English

Eligibility Diabetes NCT02016911

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02016911
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject with normal hepatic function or hepatic impairment (mild, moderate or severe)
Description

Liver function | Hepatic impairment Mild | Hepatic impairment Moderate | Hepatic impairment Severe

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C2945599
UMLS CUI [3,1]
C0948807
UMLS CUI [3,2]
C0205081
UMLS CUI [4,1]
C0948807
UMLS CUI [4,2]
C0205082
body mass index (bmi) 18.5-40.0 kg/m^2 (both inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
history of crohn's disease, ulcerative colitis, or other inflammatory bowel disease
Description

Crohn Disease | Ulcerative Colitis | Inflammatory Bowel Disease

Data type

boolean

Alias
UMLS CUI [1]
C0010346
UMLS CUI [2]
C0009324
UMLS CUI [3]
C0021390
uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg)
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
any donation of blood or plasma in excess of 400 ml within the 3 months preceding screening
Description

Blood Donation Excessive Amount | Plasma Donation Excessive Amount

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0005794
UMLS CUI [2,3]
C0442802
UMLS CUI [2,4]
C1265611
history of significant drug abuse, or a positive drug test at the screening visit (visit 2)
Description

Drug abuse | Drug screening test Positive

Data type

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2,1]
C0373483
UMLS CUI [2,2]
C1514241
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Similar models

Eligibility Diabetes NCT02016911

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02016911
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver function | Hepatic impairment Mild | Hepatic impairment Moderate | Hepatic impairment Severe
Item
subject with normal hepatic function or hepatic impairment (mild, moderate or severe)
boolean
C0232741 (UMLS CUI [1])
C0948807 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0948807 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0948807 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) 18.5-40.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Crohn Disease | Ulcerative Colitis | Inflammatory Bowel Disease
Item
history of crohn's disease, ulcerative colitis, or other inflammatory bowel disease
boolean
C0010346 (UMLS CUI [1])
C0009324 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Blood Donation Excessive Amount | Plasma Donation Excessive Amount
Item
any donation of blood or plasma in excess of 400 ml within the 3 months preceding screening
boolean
C0005794 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0032105 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C0442802 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Drug abuse | Drug screening test Positive
Item
history of significant drug abuse, or a positive drug test at the screening visit (visit 2)
boolean
C0013146 (UMLS CUI [1])
C0373483 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
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