ID

29028

Beschreibung

Safety Study of BMS-816336 in Healthy Male Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00979368

Link

https://clinicaltrials.gov/show/NCT00979368

Stichworte

Versionen (1)
  1. 21.02.18 21.02.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. Februar 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Non-Insulin-Dependent NCT00979368

Englisch

Eligibility Diabetes Mellitus, Non-Insulin-Dependent NCT00979368

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male subjects
Beschreibung

Healthy subject | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0079399
bmi of 18 to 32 kg/m²
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
men only, ages 18-55 years
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
sexually active men not using effective birth control if their partners are wocbp
Beschreibung

Gender Sexually active | Contraceptive methods Lacking | Partner Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C3831118
any significant acute or chronic medical illness
Beschreibung

Illness | Chronic disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2]
C0008679
family history of gilbert's disease
Beschreibung

Family history Gilbert Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0017551
history of pancreatitis
Beschreibung

Pancreatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0030305
evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, egg or clinical laboratory determinations
Beschreibung

Organ dysfunction | Abnormality Physical Examination | Abnormal vital signs | Electrocardiogram abnormal | Laboratory test result abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0349410
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0031809
UMLS CUI [3]
C0277804
UMLS CUI [4]
C0522055
UMLS CUI [5]
C0438215
qtc interval > 450 msec (corrected for heart rate using fridericia's correction method, qtcf)
Beschreibung

QTc interval QTcF - Fridericia's Correction Formula

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C1882513
second- or third-degree a-v block or clinically relevant ecg abnormalities
Beschreibung

Second degree atrioventricular block | Complete atrioventricular block | Electrocardiogram abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3]
C0522055
history of allergy to 11-β-hsd-1 inhibitors or related compounds
Beschreibung

Hypersensitivity 11-beta-Hydroxysteroid Dehydrogenase inhibitors | Hypersensitivity Compound Related

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0044707
UMLS CUI [1,3]
C0243077
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C0439849
prior exposure to bms-816336
Beschreibung

Exposure to Substance Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0439861
UMLS CUI [1,3]
C0205369
use of st. john's wort (hypericum) within 4 weeks prior to the first dose of study drug and throughout the study
Beschreibung

Hypericum perforatum

Datentyp

boolean

Alias
UMLS CUI [1]
C0936242
use of an oral, injectable, inhalable or suspension of glucocorticoid agents within 12 weeks of study drug administration
Beschreibung

Glucocorticoids Oral | Glucocorticoids Injectable | Glucocorticoids Inhalant | Glucocorticoids Suspension

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C0086466
UMLS CUI [3,1]
C0017710
UMLS CUI [3,2]
C0001559
UMLS CUI [4,1]
C0017710
UMLS CUI [4,2]
C0038960
use of any glucocorticoid topical creams within 4 weeks of study drug administration
Beschreibung

Glucocorticoid Topical Cream

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C0991551
use of oral, injectable, or topical androgen agent within 12 weeks prior to enrollment
Beschreibung

Androgen Oral | Androgen Injectable | Androgen Topical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3536949
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C3536949
UMLS CUI [2,2]
C0086466
UMLS CUI [3,1]
C3536949
UMLS CUI [3,2]
C1522168
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Non-Insulin-Dependent NCT00979368

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy subject | Gender
Item
healthy male subjects
boolean
C1708335 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Body mass index
Item
bmi of 18 to 32 kg/m²
boolean
C1305855 (UMLS CUI [1])
Gender | Age
Item
men only, ages 18-55 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Gender Sexually active | Contraceptive methods Lacking | Partner Childbearing Potential
Item
sexually active men not using effective birth control if their partners are wocbp
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0682323 (UMLS CUI [3,1])
C3831118 (UMLS CUI [3,2])
Illness | Chronic disease
Item
any significant acute or chronic medical illness
boolean
C0221423 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Family history Gilbert Disease
Item
family history of gilbert's disease
boolean
C0241889 (UMLS CUI [1,1])
C0017551 (UMLS CUI [1,2])
Pancreatitis
Item
history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Organ dysfunction | Abnormality Physical Examination | Abnormal vital signs | Electrocardiogram abnormal | Laboratory test result abnormal
Item
evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, egg or clinical laboratory determinations
boolean
C0349410 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0277804 (UMLS CUI [3])
C0522055 (UMLS CUI [4])
C0438215 (UMLS CUI [5])
QTc interval QTcF - Fridericia's Correction Formula
Item
qtc interval > 450 msec (corrected for heart rate using fridericia's correction method, qtcf)
boolean
C0489625 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
Second degree atrioventricular block | Complete atrioventricular block | Electrocardiogram abnormal
Item
second- or third-degree a-v block or clinically relevant ecg abnormalities
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0522055 (UMLS CUI [3])
Hypersensitivity 11-beta-Hydroxysteroid Dehydrogenase inhibitors | Hypersensitivity Compound Related
Item
history of allergy to 11-β-hsd-1 inhibitors or related compounds
boolean
C0020517 (UMLS CUI [1,1])
C0044707 (UMLS CUI [1,2])
C0243077 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Exposure to Substance Specified
Item
prior exposure to bms-816336
boolean
C0332157 (UMLS CUI [1,1])
C0439861 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Hypericum perforatum
Item
use of st. john's wort (hypericum) within 4 weeks prior to the first dose of study drug and throughout the study
boolean
C0936242 (UMLS CUI [1])
Glucocorticoids Oral | Glucocorticoids Injectable | Glucocorticoids Inhalant | Glucocorticoids Suspension
Item
use of an oral, injectable, inhalable or suspension of glucocorticoid agents within 12 weeks of study drug administration
boolean
C0017710 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0017710 (UMLS CUI [2,1])
C0086466 (UMLS CUI [2,2])
C0017710 (UMLS CUI [3,1])
C0001559 (UMLS CUI [3,2])
C0017710 (UMLS CUI [4,1])
C0038960 (UMLS CUI [4,2])
Glucocorticoid Topical Cream
Item
use of any glucocorticoid topical creams within 4 weeks of study drug administration
boolean
C0017710 (UMLS CUI [1,1])
C0991551 (UMLS CUI [1,2])
Androgen Oral | Androgen Injectable | Androgen Topical
Item
use of oral, injectable, or topical androgen agent within 12 weeks prior to enrollment
boolean
C3536949 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3536949 (UMLS CUI [2,1])
C0086466 (UMLS CUI [2,2])
C3536949 (UMLS CUI [3,1])
C1522168 (UMLS CUI [3,2])
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