ID

34278

Description

A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01537497

Link

https://clinicaltrials.gov/show/NCT01537497

Keywords

  1. 1/16/19 1/16/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 16, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diabetes Mellitus, Type 2 NCT01537497

Eligibility Diabetes Mellitus, Type 2 NCT01537497

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
Description

ID.1

Data type

boolean

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. in addition, subjects must have normal pulmonary function tests and normal ocular findings.
Description

ID.2

Data type

boolean

women must be of non-childbearing potential.
Description

ID.3

Data type

boolean

body mass index (bmi) of 19.5 35.5 kg/m2, and a total body weight of > 50 kg (110 lbs).
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

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 and seasonal allergies at time of dosing).
Description

ID.5

Data type

boolean

evidence or history of any chronic ongoing or current pulmonary disease.
Description

ID.6

Data type

boolean

history of smoking in the past 5 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 -7.
Description

ID.7

Data type

boolean

active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
Description

ID.8

Data type

boolean

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01537497

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
boolean
ID.2
Item
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. in addition, subjects must have normal pulmonary function tests and normal ocular findings.
boolean
ID.3
Item
women must be of non-childbearing potential.
boolean
ID.4
Item
body mass index (bmi) of 19.5 35.5 kg/m2, and a total body weight of > 50 kg (110 lbs).
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
boolean
ID.6
Item
evidence or history of any chronic ongoing or current pulmonary disease.
boolean
ID.7
Item
history of smoking in the past 5 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 -7.
boolean
ID.8
Item
active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
boolean

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial