ID

38927

Descripción

Investigation of Optimal Dosing Conditions for a Long Acting GLP-1 Analogue in Healthy Male Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01572753

Link

https://clinicaltrials.gov/show/NCT01572753

Palabras clave

Versiones (1)
  1. 13/11/19 13/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

13 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT01572753

Inglés

Eligibility Diabetes NCT01572753

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01572753
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
good general health as judged by the investigator, based on medical history, physical examination, electrocardiogram (ecg), vital signs and clinical laboratory
Descripción

General health good Medical History | General health good Physical Examination | General health good ECG | General health good Vital signs | General health good Laboratory Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1277245
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C1277245
UMLS CUI [3,2]
C1623258
UMLS CUI [4,1]
C1277245
UMLS CUI [4,2]
C0518766
UMLS CUI [5,1]
C1277245
UMLS CUI [5,2]
C0022885
body mass index (bmi) of 18.5-30.0 kg/m^2 (both inclusive)
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
males who are sexually active and not surgically sterilised, who or whose partner(s):
Descripción

Gender Sexually active Male sterilization Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0024559
UMLS CUI [1,4]
C0332197
a. are not using adequate contraceptive methods (e.g. condom with spermicidal foam/gel/film/cream or contraceptives with a pearl index below 1%, such as implants, injectables, combined oral contraceptives, or hormonal intrauterine devices or diaphragm + spermicide) or b. do not refrain from sexual intercourse during the trial and until 30 days following the last dose of trial medication. in addition, subjects must not donate sperm for the duration of the trial and for 30 days following the last dose of trial medication or c. sterilization of either partner
Descripción

Contraceptive methods Absent | Condoms | Spermicidal foam/jelly/cream/film/suppository | Contraceptive implant | Injectable contraception | Combined Oral Contraceptives | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Sexual Abstinence Absent | Sperm donation Absent | Sterilization Partner

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0677582
UMLS CUI [3]
C3843415
UMLS CUI [4]
C1657106
UMLS CUI [5]
C1262153
UMLS CUI [6]
C0009906
UMLS CUI [7]
C0021900
UMLS CUI [8]
C0042241
UMLS CUI [9]
C0087145
UMLS CUI [10,1]
C0036899
UMLS CUI [10,2]
C0332197
UMLS CUI [11,1]
C0871414
UMLS CUI [11,2]
C0332197
UMLS CUI [12,1]
C0038288
UMLS CUI [12,2]
C0682323
suffer from a life threatening disease or has a history of any clinically significant disease or disorder
Descripción

Life threatening illness | Disease Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2826293
history of acute idiopathic or chronic pancreatitis
Descripción

Idiopathic acute pancreatitis | Pancreatitis, Chronic

Tipo de datos

boolean

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

Calcitonin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201924
any clinically significant abnormal laboratory test results (haematology, biochemistry and urinalysis), as judged by the investigator and any of the following laboratory safety results (based on screening results): amylase, lipase and creatinine, above upper normal range. aspartate aminotransferase (asat), alanine aminotransferase (alat) and gamma-glutamyl-transpeptidase (gamma-gt) above 1.5 times upper normal range (unr). thrombocytes below 0.75 times lower normal range (lnr) or above 1.25 times unr. leucocytes outside 3.0 to 11.0x10^9/l (normal range is 3.91 to 8.77x10^9/l. sodium outside the range 130.0 to 150.0 mmol/l (normal range is 136-145 mmol/l). potassium outside the range 3.0 to 5.5 mmol/l (normal range is 3.5 to 5.1 mmol/l)
Descripción

Laboratory test result abnormal | Haematology test abnormal | Abnormal biochemistry finding | Urine screening abnormal | Serum amylase raised | Serum lipase raised | Serum creatinine raised | Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Decreased platelet count | Increased number of platelets | White blood cell count abnormal | Serum sodium abnormal | Serum potassium abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C1112712
UMLS CUI [3]
C0586680
UMLS CUI [4]
C0438142
UMLS CUI [5]
C0476327
UMLS CUI [6]
C3670924
UMLS CUI [7]
C0700225
UMLS CUI [8]
C0151904
UMLS CUI [9]
C0151905
UMLS CUI [10]
C0151662
UMLS CUI [11]
C0392386
UMLS CUI [12]
C0857460
UMLS CUI [13]
C0580531
UMLS CUI [14]
C0858176
UMLS CUI [15]
C0858156
any clinically significant abnormal ecg, as judged by the investigator
Descripción

ECG abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522055
subjects who are smokers
Descripción

Tobacco use

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543414
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Similar models

Eligibility Diabetes NCT01572753

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01572753
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
General health good Medical History | General health good Physical Examination | General health good ECG | General health good Vital signs | General health good Laboratory Procedures
Item
good general health as judged by the investigator, based on medical history, physical examination, electrocardiogram (ecg), vital signs and clinical laboratory
boolean
C1277245 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1277245 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1277245 (UMLS CUI [3,1])
C1623258 (UMLS CUI [3,2])
C1277245 (UMLS CUI [4,1])
C0518766 (UMLS CUI [4,2])
C1277245 (UMLS CUI [5,1])
C0022885 (UMLS CUI [5,2])
Body mass index
Item
body mass index (bmi) of 18.5-30.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender Sexually active Male sterilization Absent
Item
males who are sexually active and not surgically sterilised, who or whose partner(s):
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0024559 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Contraceptive methods Absent | Condoms | Spermicidal foam/jelly/cream/film/suppository | Contraceptive implant | Injectable contraception | Combined Oral Contraceptives | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Sexual Abstinence Absent | Sperm donation Absent | Sterilization Partner
Item
a. are not using adequate contraceptive methods (e.g. condom with spermicidal foam/gel/film/cream or contraceptives with a pearl index below 1%, such as implants, injectables, combined oral contraceptives, or hormonal intrauterine devices or diaphragm + spermicide) or b. do not refrain from sexual intercourse during the trial and until 30 days following the last dose of trial medication. in addition, subjects must not donate sperm for the duration of the trial and for 30 days following the last dose of trial medication or c. sterilization of either partner
boolean
C0700589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0677582 (UMLS CUI [2])
C3843415 (UMLS CUI [3])
C1657106 (UMLS CUI [4])
C1262153 (UMLS CUI [5])
C0009906 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
C0042241 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
C0036899 (UMLS CUI [10,1])
C0332197 (UMLS CUI [10,2])
C0871414 (UMLS CUI [11,1])
C0332197 (UMLS CUI [11,2])
C0038288 (UMLS CUI [12,1])
C0682323 (UMLS CUI [12,2])
Life threatening illness | Disease Clinical Significance
Item
suffer from a life threatening disease or has a history of any clinically significant disease or disorder
boolean
C3846017 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Idiopathic acute pancreatitis | Pancreatitis, Chronic
Item
history of acute idiopathic or chronic pancreatitis
boolean
C0341461 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Calcitonin measurement
Item
calcitonin value equal to or above 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Laboratory test result abnormal | Haematology test abnormal | Abnormal biochemistry finding | Urine screening abnormal | Serum amylase raised | Serum lipase raised | Serum creatinine raised | Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Decreased platelet count | Increased number of platelets | White blood cell count abnormal | Serum sodium abnormal | Serum potassium abnormal
Item
any clinically significant abnormal laboratory test results (haematology, biochemistry and urinalysis), as judged by the investigator and any of the following laboratory safety results (based on screening results): amylase, lipase and creatinine, above upper normal range. aspartate aminotransferase (asat), alanine aminotransferase (alat) and gamma-glutamyl-transpeptidase (gamma-gt) above 1.5 times upper normal range (unr). thrombocytes below 0.75 times lower normal range (lnr) or above 1.25 times unr. leucocytes outside 3.0 to 11.0x10^9/l (normal range is 3.91 to 8.77x10^9/l. sodium outside the range 130.0 to 150.0 mmol/l (normal range is 136-145 mmol/l). potassium outside the range 3.0 to 5.5 mmol/l (normal range is 3.5 to 5.1 mmol/l)
boolean
C0438215 (UMLS CUI [1])
C1112712 (UMLS CUI [2])
C0586680 (UMLS CUI [3])
C0438142 (UMLS CUI [4])
C0476327 (UMLS CUI [5])
C3670924 (UMLS CUI [6])
C0700225 (UMLS CUI [7])
C0151904 (UMLS CUI [8])
C0151905 (UMLS CUI [9])
C0151662 (UMLS CUI [10])
C0392386 (UMLS CUI [11])
C0857460 (UMLS CUI [12])
C0580531 (UMLS CUI [13])
C0858176 (UMLS CUI [14])
C0858156 (UMLS CUI [15])
ECG abnormal
Item
any clinically significant abnormal ecg, as judged by the investigator
boolean
C0522055 (UMLS CUI [1])
Tobacco use
Item
subjects who are smokers
boolean
C0543414 (UMLS CUI [1])
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