ID

38647

Beschreibung

A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01396161

Link

https://clinicaltrials.gov/show/NCT01396161

Stichworte

Versionen (1)
  1. 29.10.19 29.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. Oktober 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01396161

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT01396161

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests.
Beschreibung

Healthy | Age | Abnormality Clinical Absent | Medical History | Physical Examination | Blood pressure determination | Pulse rate finding | 12 lead ECG | Laboratory Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0205210
UMLS CUI [3,3]
C0332197
UMLS CUI [4]
C0262926
UMLS CUI [5]
C0031809
UMLS CUI [6]
C0005824
UMLS CUI [7]
C0577836
UMLS CUI [8]
C0430456
UMLS CUI [9]
C0022885
in addition, subjects must have normal pulmonary function tests and normal ocular examination.
Beschreibung

Pulmonary function tests | Ophthalmic examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2]
C0200149
body mass index (bmi) of 25.5 - 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
Beschreibung

Body mass index | Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
women must be of non-childbearing potential.
Beschreibung

Gender Childbearing Potential Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
subjects with type 2 diabetes: hba1c ≥7.0% and ≤10.0% if on metformin only, and ≥6.5% and ≤9.0% if patient requires to be washed-off an su or dpp-4i.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Metformin | Requirement Washout Sulfonylurea | Requirement Washout Dipeptidyl Peptidase 4 Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0025598
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C1710661
UMLS CUI [4,3]
C0038766
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C1710661
UMLS CUI [5,3]
C2917254
for subjects with type 2 diabetes, due to possible effects on disposition, cyp p450 3a4/5 and 2d6 substrates should not be co-administered with study medications.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | CYP3A4 Substrate Absent | CYP3A5 Substrate Absent | CYP2D6 Substrate Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C3714798
UMLS CUI [2,2]
C3891814
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3714750
UMLS CUI [3,2]
C3891814
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0057223
UMLS CUI [4,2]
C3891814
UMLS CUI [4,3]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic seasonal allergies at time of dosing).
Beschreibung

Hematological Disease | Kidney Disease | Endocrine System Disease | Gastrointestinal Disease | Cardiovascular Disease | Liver disease | Mental disorders | Nervous system disorder | Hypersensitivity | Drug Allergy | Exception Hay fever Asymptomatic Untreated

Datentyp

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0014130
UMLS CUI [4]
C0017178
UMLS CUI [5]
C0007222
UMLS CUI [6]
C0023895
UMLS CUI [7]
C0004936
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0020517
UMLS CUI [10]
C0013182
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0018621
UMLS CUI [11,3]
C0231221
UMLS CUI [11,4]
C0332155
evidence or history of any chronic ongoing or current pulmonary disease.
Beschreibung

Chronic lung disease | Lung disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0746102
UMLS CUI [2]
C0024115
history of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products within 3 months of screening, or positive cotinine test at screening or day -3.
Beschreibung

Smoking History | Smoking cigarettes: ____ pack-years history | Non-smoked tobacco | Nicotine product | Urine cotinine test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C2230126
UMLS CUI [3]
C4296981
UMLS CUI [4]
C0028040
UMLS CUI [5]
C1699505
active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
Beschreibung

Disorder of eye | Eye Infection | Glaucoma | Hay fever | Dryness of eye Symptoms | Retinal Disease | Disorder of the optic nerve

Datentyp

boolean

Alias
UMLS CUI [1]
C0015397
UMLS CUI [2]
C0015403
UMLS CUI [3]
C0017601
UMLS CUI [4]
C0018621
UMLS CUI [5,1]
C0314719
UMLS CUI [5,2]
C1457887
UMLS CUI [6]
C0035309
UMLS CUI [7]
C0029132
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT01396161

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy | Age | Abnormality Clinical Absent | Medical History | Physical Examination | Blood pressure determination | Pulse rate finding | 12 lead ECG | Laboratory Procedures
Item
healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests.
boolean
C3898900 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0262926 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0005824 (UMLS CUI [6])
C0577836 (UMLS CUI [7])
C0430456 (UMLS CUI [8])
C0022885 (UMLS CUI [9])
Pulmonary function tests | Ophthalmic examination
Item
in addition, subjects must have normal pulmonary function tests and normal ocular examination.
boolean
C0024119 (UMLS CUI [1])
C0200149 (UMLS CUI [2])
Body mass index | Body Weight
Item
body mass index (bmi) of 25.5 - 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Gender Childbearing Potential Absent
Item
women must be of non-childbearing potential.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Metformin | Requirement Washout Sulfonylurea | Requirement Washout Dipeptidyl Peptidase 4 Inhibitors
Item
subjects with type 2 diabetes: hba1c ≥7.0% and ≤10.0% if on metformin only, and ≥6.5% and ≤9.0% if patient requires to be washed-off an su or dpp-4i.
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C1710661 (UMLS CUI [4,2])
C0038766 (UMLS CUI [4,3])
C1514873 (UMLS CUI [5,1])
C1710661 (UMLS CUI [5,2])
C2917254 (UMLS CUI [5,3])
Diabetes Mellitus, Non-Insulin-Dependent | CYP3A4 Substrate Absent | CYP3A5 Substrate Absent | CYP2D6 Substrate Absent
Item
for subjects with type 2 diabetes, due to possible effects on disposition, cyp p450 3a4/5 and 2d6 substrates should not be co-administered with study medications.
boolean
C0011860 (UMLS CUI [1])
C3714798 (UMLS CUI [2,1])
C3891814 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3714750 (UMLS CUI [3,1])
C3891814 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0057223 (UMLS CUI [4,1])
C3891814 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Hematological Disease | Kidney Disease | Endocrine System Disease | Gastrointestinal Disease | Cardiovascular Disease | Liver disease | Mental disorders | Nervous system disorder | Hypersensitivity | Drug Allergy | Exception Hay fever Asymptomatic Untreated
Item
evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic seasonal allergies at time of dosing).
boolean
C0018939 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0007222 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0020517 (UMLS CUI [9])
C0013182 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0018621 (UMLS CUI [11,2])
C0231221 (UMLS CUI [11,3])
C0332155 (UMLS CUI [11,4])
Chronic lung disease | Lung disease
Item
evidence or history of any chronic ongoing or current pulmonary disease.
boolean
C0746102 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
Smoking History | Smoking cigarettes: ____ pack-years history | Non-smoked tobacco | Nicotine product | Urine cotinine test positive
Item
history of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products within 3 months of screening, or positive cotinine test at screening or day -3.
boolean
C1519384 (UMLS CUI [1])
C2230126 (UMLS CUI [2])
C4296981 (UMLS CUI [3])
C0028040 (UMLS CUI [4])
C1699505 (UMLS CUI [5])
Disorder of eye | Eye Infection | Glaucoma | Hay fever | Dryness of eye Symptoms | Retinal Disease | Disorder of the optic nerve
Item
active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
boolean
C0015397 (UMLS CUI [1])
C0015403 (UMLS CUI [2])
C0017601 (UMLS CUI [3])
C0018621 (UMLS CUI [4])
C0314719 (UMLS CUI [5,1])
C1457887 (UMLS CUI [5,2])
C0035309 (UMLS CUI [6])
C0029132 (UMLS CUI [7])
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