ID

33654

Description

Single Dose Study of PF-04991532 in Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01102673

Link

https://clinicaltrials.gov/show/NCT01102673

Keywords

Versions (1)
  1. 12/18/18 12/18/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 18, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT01102673

English

Eligibility Diabetes Mellitus NCT01102673

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male and/or female (non child-bearing potential) 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).
Description

Healthy Volunteers | Childbearing Potential Absent | Age | Abnormality Absent | Medical History | Physical Examination | Blood pressure determination | Pulse Rate | 12 lead ECG | Laboratory Procedures

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C1704258
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0262926
UMLS CUI [6]
C0031809
UMLS CUI [7]
C0005824
UMLS CUI [8]
C0232117
UMLS CUI [9]
C0430456
UMLS CUI [10]
C0022885
body mass index (bmi) of 17.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
Description

Body mass index | Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
Exclusion Criteria
Description

Exclusion Criteria

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

Hematological Disease | Kidney Disease | Endocrine System Disease | Lung disease | Gastrointestinal Disease | Cardiovascular Disease | Liver disease | Mental disorder | Nervous system disorder | Disease allergic | Drug Allergy | Exception Hypersensitivity Untreated | Exception Hypersensitivity Asymptomatic | Exception Seasonal allergies

Data type

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0014130
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0007222
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0004936
UMLS CUI [9]
C0027765
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0700624
UMLS CUI [11]
C0013182
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0020517
UMLS CUI [12,3]
C0332155
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0020517
UMLS CUI [13,3]
C0231221
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0018621
any condition possibly affecting drug absorption (eg, gastrectomy).
Description

Condition Affecting Drug absorption | Gastrectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678745
UMLS CUI [2]
C0017118
history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening.
Description

Alcohol consumption Regular Drinks per week | Gender | Wine oz/week | Beer oz/week | Hard liquor intake oz/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0001967
UMLS CUI [1,4]
C0332174
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0043188
UMLS CUI [3,2]
C0556977
UMLS CUI [4,1]
C0004922
UMLS CUI [4,2]
C0556977
UMLS CUI [5,1]
C0559433
UMLS CUI [5,2]
C0556977
use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
Description

Tobacco use Number of cigarettes per day | Nicotine product Equivalent Number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
UMLS CUI [2,1]
C0028040
UMLS CUI [2,2]
C0205163
UMLS CUI [2,3]
C3694146
self-reported history of hypoglycemia, or fasting laboratory glucose value </=80 mg/dl at screening or day 0 of period 1, confirmed by a single repeat if deemed necessary.
Description

Hypoglycemia | Glucose measurement, fasting

Data type

boolean

Alias
UMLS CUI [1]
C0020615
UMLS CUI [2]
C0202045
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Similar models

Eligibility Diabetes Mellitus NCT01102673

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Childbearing Potential Absent | Age | Abnormality Absent | Medical History | Physical Examination | Blood pressure determination | Pulse Rate | 12 lead ECG | Laboratory Procedures
Item
healthy male and/or female (non child-bearing potential) 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
C1708335 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C1704258 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0262926 (UMLS CUI [5])
C0031809 (UMLS CUI [6])
C0005824 (UMLS CUI [7])
C0232117 (UMLS CUI [8])
C0430456 (UMLS CUI [9])
C0022885 (UMLS CUI [10])
Body mass index | Body Weight
Item
body mass index (bmi) of 17.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hematological Disease | Kidney Disease | Endocrine System Disease | Lung disease | Gastrointestinal Disease | Cardiovascular Disease | Liver disease | Mental disorder | Nervous system disorder | Disease allergic | Drug Allergy | Exception Hypersensitivity Untreated | Exception Hypersensitivity Asymptomatic | Exception Seasonal allergies
Item
evidence or history of clinically significant hematological, renal, endocrine, pulmonary, 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])
C0024115 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0012634 (UMLS CUI [10,1])
C0700624 (UMLS CUI [10,2])
C0013182 (UMLS CUI [11])
C1705847 (UMLS CUI [12,1])
C0020517 (UMLS CUI [12,2])
C0332155 (UMLS CUI [12,3])
C1705847 (UMLS CUI [13,1])
C0020517 (UMLS CUI [13,2])
C0231221 (UMLS CUI [13,3])
C1705847 (UMLS CUI [14,1])
C0018621 (UMLS CUI [14,2])
Condition Affecting Drug absorption | Gastrectomy
Item
any condition possibly affecting drug absorption (eg, gastrectomy).
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0017118 (UMLS CUI [2])
Alcohol consumption Regular Drinks per week | Gender | Wine oz/week | Beer oz/week | Hard liquor intake oz/week
Item
history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening.
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0001967 (UMLS CUI [1,3])
C0332174 (UMLS CUI [1,4])
C0079399 (UMLS CUI [2])
C0043188 (UMLS CUI [3,1])
C0556977 (UMLS CUI [3,2])
C0004922 (UMLS CUI [4,1])
C0556977 (UMLS CUI [4,2])
C0559433 (UMLS CUI [5,1])
C0556977 (UMLS CUI [5,2])
Tobacco use Number of cigarettes per day | Nicotine product Equivalent Number of cigarettes per day
Item
use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C0028040 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C3694146 (UMLS CUI [2,3])
Hypoglycemia | Glucose measurement, fasting
Item
self-reported history of hypoglycemia, or fasting laboratory glucose value </=80 mg/dl at screening or day 0 of period 1, confirmed by a single repeat if deemed necessary.
boolean
C0020615 (UMLS CUI [1])
C0202045 (UMLS CUI [2])
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