ID

38994

Descripción

A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT02146079

Link

https://clinicaltrials.gov/show/NCT02146079

Palabras clave

Versiones (1)
  1. 18/11/19 18/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT02146079

Inglés

Eligibility Diabetes NCT02146079

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02146079
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male japanese and caucasian subjects
Descripción

Gender | Healthy Volunteers | Japanese | Caucasians

Tipo de datos

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 the time of signing informed consent
Descripción

Age | Informed Consent

Tipo de datos

boolean

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

Body Weight

Tipo de datos

boolean

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

Body mass index

Tipo de datos

boolean

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

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
for japanese subjects only: both parents japanese
Descripción

Japanese | Parent Both Japanese

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2,1]
C0030551
UMLS CUI [2,2]
C1706086
UMLS CUI [2,3]
C1556094
for caucasian subjects only: both parents caucasian
Descripción

Caucasians | Parent Both Caucasian

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0043157
UMLS CUI [2,1]
C0030551
UMLS CUI [2,2]
C1706086
UMLS CUI [2,3]
C0043157
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
Descripción

Disease Clinical Significance | Systemic disease | Organ Disease | Heart Diseases | Lung diseases | Gastrointestinal Diseases | Liver diseases | Nervous system disorder | Kidney Diseases | Disorder of the genitourinary system | Endocrine System Diseases | Dermatologic disorders | Hematological Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0442893
UMLS CUI [3,1]
C0178784
UMLS CUI [3,2]
C0012634
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0024115
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0022658
UMLS CUI [10]
C0080276
UMLS CUI [11]
C0014130
UMLS CUI [12]
C0037274
UMLS CUI [13]
C0018939
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (men2)
Descripción

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

Tipo de datos

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
Descripción

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
calcitonin above or equal to 50 ng/l
Descripción

Calcitonin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201924
history of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 ml of beer or lager, or approximately120 ml (one glass) of wine or japanese sake, or approximately 20 ml of spirits
Descripción

Alcohol abuse | Breath alcohol test positive | Alcohol consumption units/week | Beer units/week | Lager units/week | Wine units/week | Sake units/week | Spirits units/week

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C1112499
UMLS CUI [3,1]
C0001948
UMLS CUI [3,2]
C0560579
UMLS CUI [4,1]
C0004922
UMLS CUI [4,2]
C0560579
UMLS CUI [5,1]
C0452245
UMLS CUI [5,2]
C0560579
UMLS CUI [6,1]
C0043188
UMLS CUI [6,2]
C0560579
UMLS CUI [7,1]
C0678393
UMLS CUI [7,2]
C0560579
UMLS CUI [8,1]
C0301611
UMLS CUI [8,2]
C0560579
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
Descripción

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

Tipo de datos

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 (randomisation), non-prescription drugs within 1 week prior to visit 2 (randomisation). the use of vitamins, minerals and nutritional supplements, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted
Descripción

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

Tipo de datos

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]
C0242295
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0000970
UMLS CUI [6,2]
C0521114
UMLS CUI [6,3]
C0683607
UMLS CUI [7,1]
C0004057
UMLS CUI [7,2]
C0521114
UMLS CUI [7,3]
C0683607
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Similar models

Eligibility Diabetes NCT02146079

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02146079
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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 the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Body Weight
Item
body weight of equal to or above 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])
Japanese | Parent Both Japanese
Item
for japanese subjects only: both parents japanese
boolean
C1556094 (UMLS CUI [1])
C0030551 (UMLS CUI [2,1])
C1706086 (UMLS CUI [2,2])
C1556094 (UMLS CUI [2,3])
Caucasians | Parent Both Caucasian
Item
for caucasian subjects only: both parents caucasian
boolean
C0043157 (UMLS CUI [1])
C0030551 (UMLS CUI [2,1])
C1706086 (UMLS CUI [2,2])
C0043157 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Disease Clinical Significance | Systemic disease | Organ Disease | Heart Diseases | Lung diseases | Gastrointestinal Diseases | Liver diseases | Nervous system disorder | Kidney Diseases | Disorder of the genitourinary system | Endocrine System Diseases | Dermatologic disorders | Hematological Disease
Item
any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2])
C0178784 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0022658 (UMLS CUI [9])
C0080276 (UMLS CUI [10])
C0014130 (UMLS CUI [11])
C0037274 (UMLS CUI [12])
C0018939 (UMLS CUI [13])
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 or multiple endocrine neoplasia syndrome 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])
Calcitonin measurement
Item
calcitonin above or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Alcohol abuse | Breath alcohol test positive | Alcohol consumption units/week | Beer units/week | Lager units/week | Wine units/week | Sake units/week | Spirits units/week
Item
history of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 ml of beer or lager, or approximately120 ml (one glass) of wine or japanese sake, or approximately 20 ml of spirits
boolean
C0085762 (UMLS CUI [1])
C1112499 (UMLS CUI [2])
C0001948 (UMLS CUI [3,1])
C0560579 (UMLS CUI [3,2])
C0004922 (UMLS CUI [4,1])
C0560579 (UMLS CUI [4,2])
C0452245 (UMLS CUI [5,1])
C0560579 (UMLS CUI [5,2])
C0043188 (UMLS CUI [6,1])
C0560579 (UMLS CUI [6,2])
C0678393 (UMLS CUI [7,1])
C0560579 (UMLS CUI [7,2])
C0301611 (UMLS CUI [8,1])
C0560579 (UMLS CUI [8,2])
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 | Dietary Supplements 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 (randomisation), non-prescription drugs within 1 week prior to visit 2 (randomisation). the use of vitamins, minerals and nutritional supplements, 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])
C0242295 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0000970 (UMLS CUI [6,1])
C0521114 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C0004057 (UMLS CUI [7,1])
C0521114 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
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