ID

22276

Descripción

Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin; ODM derived from: https://clinicaltrials.gov/show/NCT00411190

Link

https://clinicaltrials.gov/show/NCT00411190

Palabras clave

Versiones (1)
  1. 28/5/17 28/5/17 -
Subido en

28 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Osteoporosis NCT00411190

Inglés

Eligibility Osteoporosis NCT00411190

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy
Descripción

Healthy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3898900
postmenopausal
Descripción

Postmenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
body weight > 50 kg
Descripción

Body Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005910
body mass index (bmi) between 19 and 30
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
the subject is willing and able to give a signed and dated written informed consent prior to admission to the study
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
the subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with known morphea or sclerodermia
Descripción

Morphea | Scleroderma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
subjects with a history of myocardial infarction.
Descripción

Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
subjects with a history of renal/or hepatic disease unless the disease has been successfully treated and is no longer active; subjects with any evidence of renal/ or hepatic impairment on the screening physical and laboratory examination.
Descripción

Kidney Disease | Liver disease | Renal Insufficiency Physical Examination | Hepatic impairment Physical Examination | Renal Insufficiency Laboratory Procedures | Hepatic impairment Laboratory Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0031809
UMLS CUI [4,1]
C0948807
UMLS CUI [4,2]
C0031809
UMLS CUI [5,1]
C1565489
UMLS CUI [5,2]
C0022885
UMLS CUI [6,1]
C0948807
UMLS CUI [6,2]
C0022885
subjects with history of hypertension or systolic blood pressure
Descripción

Hypertensive disease | Systolic Pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
subjects with history of diabetes
Descripción

Diabetes Mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
history of regular alcohol consumption exceeding 7 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Descripción

Alcohol consumption Regular | Wine intake Quantity Weekly | Beer intake Quantity Weekly | Hard liquor intake Quantity Weekly

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0559432
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332174
UMLS CUI [3,1]
C0559430
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0332174
UMLS CUI [4,1]
C0559433
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0332174
history of use of tobacco- or nicotine-containing products within 6 months of screening, or a positive urine cotinine indicative of smoking at screening.
Descripción

Tobacco use | Product Containing Nicotine | Urine cotinine test positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2,1]
C1514468
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0028040
UMLS CUI [3]
C1699505
positive urine drug screen including alcohol (or alcohol breath test) at screening.
Descripción

Urine drug screen positive | Urine alcohol test positive | Breath alcohol test positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C1112219
UMLS CUI [3]
C1112499
positive for hiv, hepatitis b virus or hepatitis c virus.
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C2748184
UMLS CUI [3]
C2748185
donation of blood in excess of 500 ml within 56 days prior to dosing
Descripción

Blood Donation Excess Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1979886
UMLS CUI [1,3]
C1265611
history of sensitivity or contraindications to any of the study medications (i.e., relacatib, paracetamol, ibuprofen or atorvastatin) or components thereof.
Descripción

Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs | Hypersensitivity Investigational New Drugs Component | Medical contraindication Investigational New Drugs Component | relacatib | Acetaminophen | Ibuprofen | atorvastatin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C1705248
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C1705248
UMLS CUI [5]
C1700101
UMLS CUI [6]
C0000970
UMLS CUI [7]
C0020740
UMLS CUI [8]
C0286651
treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
subjects whom are judged by the investigator to be at risk for acute angle closure glaucoma.
Descripción

Study Subject At risk Angle Closure Glaucoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0017605
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Similar models

Eligibility Osteoporosis NCT00411190

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Healthy
Item
healthy
boolean
C3898900 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal
boolean
C0232970 (UMLS CUI [1])
Body Weight
Item
body weight > 50 kg
boolean
C0005910 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 19 and 30
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
the subject is willing and able to give a signed and dated written informed consent prior to admission to the study
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
the subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Morphea | Scleroderma
Item
subjects with known morphea or sclerodermia
boolean
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
Myocardial Infarction
Item
subjects with a history of myocardial infarction.
boolean
C0027051 (UMLS CUI [1])
Kidney Disease | Liver disease | Renal Insufficiency Physical Examination | Hepatic impairment Physical Examination | Renal Insufficiency Laboratory Procedures | Hepatic impairment Laboratory Procedures
Item
subjects with a history of renal/or hepatic disease unless the disease has been successfully treated and is no longer active; subjects with any evidence of renal/ or hepatic impairment on the screening physical and laboratory examination.
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C1565489 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C0948807 (UMLS CUI [4,1])
C0031809 (UMLS CUI [4,2])
C1565489 (UMLS CUI [5,1])
C0022885 (UMLS CUI [5,2])
C0948807 (UMLS CUI [6,1])
C0022885 (UMLS CUI [6,2])
Hypertensive disease | Systolic Pressure
Item
subjects with history of hypertension or systolic blood pressure
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Diabetes Mellitus
Item
subjects with history of diabetes
boolean
C0011849 (UMLS CUI [1])
Alcohol consumption Regular | Wine intake Quantity Weekly | Beer intake Quantity Weekly | Hard liquor intake Quantity Weekly
Item
history of regular alcohol consumption exceeding 7 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0559432 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
C0559430 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0332174 (UMLS CUI [3,3])
C0559433 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0332174 (UMLS CUI [4,3])
Tobacco use | Product Containing Nicotine | Urine cotinine test positive
Item
history of use of tobacco- or nicotine-containing products within 6 months of screening, or a positive urine cotinine indicative of smoking at screening.
boolean
C0543414 (UMLS CUI [1])
C1514468 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0028040 (UMLS CUI [2,3])
C1699505 (UMLS CUI [3])
Urine drug screen positive | Urine alcohol test positive | Breath alcohol test positive
Item
positive urine drug screen including alcohol (or alcohol breath test) at screening.
boolean
C0743300 (UMLS CUI [1])
C1112219 (UMLS CUI [2])
C1112499 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B virus test positive | Hepatitis C virus test positive
Item
positive for hiv, hepatitis b virus or hepatitis c virus.
boolean
C0019699 (UMLS CUI [1])
C2748184 (UMLS CUI [2])
C2748185 (UMLS CUI [3])
Blood Donation Excess Quantity
Item
donation of blood in excess of 500 ml within 56 days prior to dosing
boolean
C0005794 (UMLS CUI [1,1])
C1979886 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs | Medical contraindication Investigational New Drugs | Hypersensitivity Investigational New Drugs Component | Medical contraindication Investigational New Drugs Component | relacatib | Acetaminophen | Ibuprofen | atorvastatin
Item
history of sensitivity or contraindications to any of the study medications (i.e., relacatib, paracetamol, ibuprofen or atorvastatin) or components thereof.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C1301624 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
C1700101 (UMLS CUI [5])
C0000970 (UMLS CUI [6])
C0020740 (UMLS CUI [7])
C0286651 (UMLS CUI [8])
Investigational New Drugs
Item
treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
boolean
C0013230 (UMLS CUI [1])
Study Subject At risk Angle Closure Glaucoma
Item
subjects whom are judged by the investigator to be at risk for acute angle closure glaucoma.
boolean
C0681850 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0017605 (UMLS CUI [1,3])
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