ID

16081

Description

Safety, Tolerability and PK of Imeglimin in Japanese Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT02373150

Link

https://clinicaltrials.gov/show/NCT02373150

Keywords

Versions (1)
  1. 6/28/16 6/28/16 -
Uploaded on

June 28, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 2 Diabetes Mellitus NCT02373150

English

Eligibility Type 2 Diabetes Mellitus NCT02373150

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female japanese subjects, deemed healthy on the basis of a clinical history, physical examination, ecg, vital signs, and laboratory tests of blood and urine
Description

Gender | Japanese | Healthy | Physical Examination | Electrocardiography | Vital signs | Hematologic Tests | Urinalysis

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C1556094
UMLS CUI [3]
C3898900
UMLS CUI [4]
C0031809
UMLS CUI [5]
C1623258
UMLS CUI [6]
C0518766
UMLS CUI [7]
C0018941
UMLS CUI [8]
C0042014
body mass index in the range 18.0-25.0 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
willing to use reliable contraception
Description

Contraceptive methods Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
able to give fully informed written consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
Description

Pregnancy | Breast Feeding | Gender Sex Behavior Childbearing Potential Contraceptive methods Not used

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0036864
UMLS CUI [3,3]
C3831118
UMLS CUI [3,4]
C0700589
UMLS CUI [3,5]
C0445107
clinically relevant abnormal findings at the screening assessment
Description

abnormal findings Relevant Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C0159131
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
clinically significant vital signs outside the acceptable range at screening
Description

Vital signs Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2826293
clinically relevant abnormal medical history, surgery or concurrent medical condition
Description

Medical History Abnormal Relevant Clinical | Operative Surgical Procedures Abnormal Relevant Clinical | medical condition Abnormal Relevant Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2347946
UMLS CUI [1,4]
C0205210
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205161
UMLS CUI [2,3]
C2347946
UMLS CUI [2,4]
C0205210
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205161
UMLS CUI [3,3]
C2347946
UMLS CUI [3,4]
C0205210
acute or chronic illness
Description

Acute illness | Chronic disease

Data type

boolean

Alias
UMLS CUI [1]
C4061114
UMLS CUI [2]
C0008679
estimated glomerular filtration rate less than 80 ml/min/1.73 m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
severe adverse reaction to any drug or sensitivity to the trial medication or its components
Description

Adverse reaction to drug Severe | Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C1705248
significant food allergy; vegetarian or vegan
Description

Food Allergy Significant | Vegetarian | Vegan

Data type

boolean

Alias
UMLS CUI [1,1]
C0016470
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0042441
UMLS CUI [3]
C2987738
use of vitamins, herbal medicines, or over-the-counter medication (with the exception of paracetamol [acetaminophen]) within 7 days before first dose of trial medication, or prescribed medication during the 14 days before first dose of trial medication
Description

Vitamins | Herbal medicine | Drugs, Non-Prescription | Acetaminophen | Prescribed medications

Data type

boolean

Alias
UMLS CUI [1]
C0042890
UMLS CUI [2]
C2240391
UMLS CUI [3]
C0013231
UMLS CUI [4]
C0000970
UMLS CUI [5]
C3166216
participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 ml blood, within the 3 months before first dose of trial medication
Description

Study Subject Participation Status Illicit Drugs | Study Subject Participation Status Prescribed medications | Blood Loss

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0086190
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C3166216
UMLS CUI [3]
C3163616
drug or alcohol abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
smoking of more than 5 cigarettes daily
Description

Cigarette smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337667
possibility that subject will not cooperate
Description

Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
positive test for hepatitis b & c, hiv
Description

Hepatitis B test positive | Hepatitis C test positive | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C1608966
UMLS CUI [2]
C1609517
UMLS CUI [3]
C0019699
objection by a general practitioner.
Description

doubt General Practitioner

Data type

boolean

Alias
UMLS CUI [1,1]
C0870444
UMLS CUI [1,2]
C0017319
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT02373150

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Japanese | Healthy | Physical Examination | Electrocardiography | Vital signs | Hematologic Tests | Urinalysis
Item
male or female japanese subjects, deemed healthy on the basis of a clinical history, physical examination, ecg, vital signs, and laboratory tests of blood and urine
boolean
C0079399 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
C3898900 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C0518766 (UMLS CUI [6])
C0018941 (UMLS CUI [7])
C0042014 (UMLS CUI [8])
Body mass index
Item
body mass index in the range 18.0-25.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Contraceptive methods Willing
Item
willing to use reliable contraception
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Informed consent
Item
able to give fully informed written consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Gender Sex Behavior Childbearing Potential Contraceptive methods Not used
Item
pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036864 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0700589 (UMLS CUI [3,4])
C0445107 (UMLS CUI [3,5])
abnormal findings Relevant Clinical
Item
clinically relevant abnormal findings at the screening assessment
boolean
C0159131 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Vital signs Clinical Significance
Item
clinically significant vital signs outside the acceptable range at screening
boolean
C0518766 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Medical History Abnormal Relevant Clinical | Operative Surgical Procedures Abnormal Relevant Clinical | medical condition Abnormal Relevant Clinical
Item
clinically relevant abnormal medical history, surgery or concurrent medical condition
boolean
C0262926 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
C0205210 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C2347946 (UMLS CUI [3,3])
C0205210 (UMLS CUI [3,4])
Acute illness | Chronic disease
Item
acute or chronic illness
boolean
C4061114 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate less than 80 ml/min/1.73 m2
boolean
C3811844 (UMLS CUI [1])
Adverse reaction to drug Severe | Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Component
Item
severe adverse reaction to any drug or sensitivity to the trial medication or its components
boolean
C0041755 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Food Allergy Significant | Vegetarian | Vegan
Item
significant food allergy; vegetarian or vegan
boolean
C0016470 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0042441 (UMLS CUI [2])
C2987738 (UMLS CUI [3])
Vitamins | Herbal medicine | Drugs, Non-Prescription | Acetaminophen | Prescribed medications
Item
use of vitamins, herbal medicines, or over-the-counter medication (with the exception of paracetamol [acetaminophen]) within 7 days before first dose of trial medication, or prescribed medication during the 14 days before first dose of trial medication
boolean
C0042890 (UMLS CUI [1])
C2240391 (UMLS CUI [2])
C0013231 (UMLS CUI [3])
C0000970 (UMLS CUI [4])
C3166216 (UMLS CUI [5])
Study Subject Participation Status Illicit Drugs | Study Subject Participation Status Prescribed medications | Blood Loss
Item
participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 ml blood, within the 3 months before first dose of trial medication
boolean
C2348568 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C3166216 (UMLS CUI [2,2])
C3163616 (UMLS CUI [3])
Substance Use Disorders
Item
drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Cigarette smoker
Item
smoking of more than 5 cigarettes daily
boolean
C0337667 (UMLS CUI [1])
Compliance behavior Limited
Item
possibility that subject will not cooperate
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Hepatitis B test positive | Hepatitis C test positive | HIV Seropositivity
Item
positive test for hepatitis b & c, hiv
boolean
C1608966 (UMLS CUI [1])
C1609517 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
doubt General Practitioner
Item
objection by a general practitioner.
boolean
C0870444 (UMLS CUI [1,1])
C0017319 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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