ID

38995

Description

A Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT02161588

Link

https://clinicaltrials.gov/show/NCT02161588

Keywords

Versions (1)
  1. 11/18/19 11/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02161588

English

Eligibility Diabetes NCT02161588

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02161588
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male japanese and caucasian subjects
Description

Gender | Healthy Volunteers | Japanese | Caucasians

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C1708335
UMLS CUI [3]
C1556094
UMLS CUI [4]
C0043157
age between 20 and 55 years (both inclusive) at time of signing informed consent
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
body weight of above or equal to 54.0 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
body mass index (bmi) between 20.0 and 25.0 kg/m^2 (both inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
glycosylated haemoglobin a1c (hba1c) below or equal to 6.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gi (gastrointestinal), endocrine, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, as judged by the investigator. any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Description

Diabetes Mellitus | Malignant Neoplasms | Heart Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Dermatologic disorders | Sexually Transmitted Diseases | Hematological Disease | Nervous system disorder | Mental disorders | Disease At risk Patient safety | Disease Protocol Compliance At risk

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0035204
UMLS CUI [5]
C0025517
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0017178
UMLS CUI [9]
C0014130
UMLS CUI [10]
C0037274
UMLS CUI [11]
C0036916
UMLS CUI [12]
C0018939
UMLS CUI [13]
C0027765
UMLS CUI [14]
C0004936
UMLS CUI [15,1]
C0012634
UMLS CUI [15,2]
C1444641
UMLS CUI [15,3]
C1113679
UMLS CUI [16,1]
C0012634
UMLS CUI [16,2]
C0525058
UMLS CUI [16,3]
C1444641
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)
Description

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type

Data type

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
history of chronic pancreatitis or idiopathic acute pancreatitis
Description

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
smoking of more than 5 cigarettes (including nicotine substitute products), or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure
Description

Tobacco use Number of cigarettes per day | Nicotine product Alternative | Refrain from Smoking Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
UMLS CUI [2,1]
C0028040
UMLS CUI [2,2]
C1523987
UMLS CUI [3,1]
C4086797
UMLS CUI [3,2]
C0558080
use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to visit 2 (day 1), non-prescription drugs within 1 week prior to visit 2 (day 1). the use of vitamins and minerals, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted
Description

Prescription Drugs | Drugs, Non-Prescription | Vitamins allowed | Minerals allowed | Acetaminophen occasional allowed | Aspirin occasional allowed

Data type

boolean

Alias
UMLS CUI [1]
C0304227
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C0042890
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0026162
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C0000970
UMLS CUI [5,2]
C0521114
UMLS CUI [5,3]
C0683607
UMLS CUI [6,1]
C0004057
UMLS CUI [6,2]
C0521114
UMLS CUI [6,3]
C0683607
any blood drawn in excess of 25 ml in the past month, or donation of blood or plasma in excess of 400 ml within the 3 months preceding screening
Description

Blood draw Excess Amount | Blood Donation Excess Amount | Plasma Donation Excess Amount

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1979886
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1979886
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0032105
UMLS CUI [3,2]
C0680854
UMLS CUI [3,3]
C1979886
UMLS CUI [3,4]
C1265611
previous gi surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder (e.g., cholecystectomy), pancreas or intestinal resections. exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic and gastric endoscopy
Description

Gastrointestinal Surgical Procedure | Invasive procedure Involving Esophagus | Invasive procedure Involving Stomach | Invasive procedure Involving Duodenum | Invasive procedure Involving Gallbladder | Cholecystectomy | Pancreatectomy | Intestinal resection | Exception Operative Surgical Procedures Uncomplicated | Exception Diagnostic procedure Uncomplicated | Exception Appendectomy | Exception Hernia Surgery | Exception Resection of polyp | Exception Biopsy | Exception Colonoscopy | Exception Endoscopy of stomach

Data type

boolean

Alias
UMLS CUI [1]
C0524722
UMLS CUI [2,1]
C4048276
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0014876
UMLS CUI [3,1]
C4048276
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C0038351
UMLS CUI [4,1]
C4048276
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C0013303
UMLS CUI [5,1]
C4048276
UMLS CUI [5,2]
C1314939
UMLS CUI [5,3]
C0016976
UMLS CUI [6]
C0008320
UMLS CUI [7]
C0030279
UMLS CUI [8]
C1096244
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0543467
UMLS CUI [9,3]
C0443334
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0430022
UMLS CUI [10,3]
C0443334
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0003611
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C3826215
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0521210
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0005558
UMLS CUI [15,1]
C1705847
UMLS CUI [15,2]
C0009378
UMLS CUI [16,1]
C1705847
UMLS CUI [16,2]
C0017195
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Similar models

Eligibility Diabetes NCT02161588

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02161588
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Healthy Volunteers | Japanese | Caucasians
Item
healthy male japanese and caucasian subjects
boolean
C0079399 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
C1556094 (UMLS CUI [3])
C0043157 (UMLS CUI [4])
Age | Informed Consent
Item
age between 20 and 55 years (both inclusive) at time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Body Weight
Item
body weight of above or equal to 54.0 kg
boolean
C0005910 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 20.0 and 25.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin a1c (hba1c) below or equal to 6.0%
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus | Malignant Neoplasms | Heart Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Dermatologic disorders | Sexually Transmitted Diseases | Hematological Disease | Nervous system disorder | Mental disorders | Disease At risk Patient safety | Disease Protocol Compliance At risk
Item
presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gi (gastrointestinal), endocrine, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, as judged by the investigator. any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
boolean
C0011849 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0037274 (UMLS CUI [10])
C0036916 (UMLS CUI [11])
C0018939 (UMLS CUI [12])
C0027765 (UMLS CUI [13])
C0004936 (UMLS CUI [14])
C0012634 (UMLS CUI [15,1])
C1444641 (UMLS CUI [15,2])
C1113679 (UMLS CUI [15,3])
C0012634 (UMLS CUI [16,1])
C0525058 (UMLS CUI [16,2])
C1444641 (UMLS CUI [16,3])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Tobacco use Number of cigarettes per day | Nicotine product Alternative | Refrain from Smoking Unwilling
Item
smoking of more than 5 cigarettes (including nicotine substitute products), or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C0028040 (UMLS CUI [2,1])
C1523987 (UMLS CUI [2,2])
C4086797 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Prescription Drugs | Drugs, Non-Prescription | Vitamins allowed | Minerals allowed | Acetaminophen occasional allowed | Aspirin occasional allowed
Item
use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to visit 2 (day 1), non-prescription drugs within 1 week prior to visit 2 (day 1). the use of vitamins and minerals, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted
boolean
C0304227 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042890 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0026162 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0000970 (UMLS CUI [5,1])
C0521114 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
C0004057 (UMLS CUI [6,1])
C0521114 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
Blood draw Excess Amount | Blood Donation Excess Amount | Plasma Donation Excess Amount
Item
any blood drawn in excess of 25 ml in the past month, or donation of blood or plasma in excess of 400 ml within the 3 months preceding screening
boolean
C0005834 (UMLS CUI [1,1])
C1979886 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0005794 (UMLS CUI [2,1])
C1979886 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0032105 (UMLS CUI [3,1])
C0680854 (UMLS CUI [3,2])
C1979886 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Gastrointestinal Surgical Procedure | Invasive procedure Involving Esophagus | Invasive procedure Involving Stomach | Invasive procedure Involving Duodenum | Invasive procedure Involving Gallbladder | Cholecystectomy | Pancreatectomy | Intestinal resection | Exception Operative Surgical Procedures Uncomplicated | Exception Diagnostic procedure Uncomplicated | Exception Appendectomy | Exception Hernia Surgery | Exception Resection of polyp | Exception Biopsy | Exception Colonoscopy | Exception Endoscopy of stomach
Item
previous gi surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder (e.g., cholecystectomy), pancreas or intestinal resections. exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic and gastric endoscopy
boolean
C0524722 (UMLS CUI [1])
C4048276 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0014876 (UMLS CUI [2,3])
C4048276 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0038351 (UMLS CUI [3,3])
C4048276 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0013303 (UMLS CUI [4,3])
C4048276 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0016976 (UMLS CUI [5,3])
C0008320 (UMLS CUI [6])
C0030279 (UMLS CUI [7])
C1096244 (UMLS CUI [8])
C1705847 (UMLS CUI [9,1])
C0543467 (UMLS CUI [9,2])
C0443334 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0430022 (UMLS CUI [10,2])
C0443334 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C0003611 (UMLS CUI [11,2])
C1705847 (UMLS CUI [12,1])
C3826215 (UMLS CUI [12,2])
C1705847 (UMLS CUI [13,1])
C0521210 (UMLS CUI [13,2])
C1705847 (UMLS CUI [14,1])
C0005558 (UMLS CUI [14,2])
C1705847 (UMLS CUI [15,1])
C0009378 (UMLS CUI [15,2])
C1705847 (UMLS CUI [16,1])
C0017195 (UMLS CUI [16,2])
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