ID

25569

Descrição

A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT00501397

Link

https://clinicaltrials.gov/show/NCT00501397

Palavras-chave

Versões (1)
  1. 06/09/2017 06/09/2017 -
Transferido a

6 de setembro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Eligibility Type 2 Diabetes Mellitus NCT00501397

Inglês

Eligibility Type 2 Diabetes Mellitus NCT00501397

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
are a healthy, non-smoking male or female.
Descrição

Healthy | Non-smoker

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0337672
are 18 to 55 years old, inclusive.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
have a body weight of > or equal to 110 pounds.
Descrição

Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
are a female who is unable to have any more children and have a negative pregnancy test.
Descrição

Gender Childbearing Potential Lacking | Gender Pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0427780
are willing and able to provide written informed consent before the start of any study-related procedures.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.
Descrição

Comprehension Study Protocol | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
smoke or use any tobacco products.
Descrição

Tobacco use

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0543414
have a known allergic reaction to ketoconazole or study drug.
Descrição

Ketoconazole allergy | Allergic Reaction Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0571275
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013230
have a history of regular alcohol consumption greater than 7 drinks per week for females or greater than 14 drinks per week for males.
Descrição

Alcohol consumption Regular Alcoholic drink Weekly | Gender

Tipo de dados

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
have a positive drug or alcohol or smoking test at screening or check-in to the clinic.
Descrição

Blood-drug tests Positive | Blood alcohol test positive | Smoking Test Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0868677
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C0948726
UMLS CUI [3,1]
C0037369
UMLS CUI [3,2]
C0039593
UMLS CUI [3,3]
C1514241
have participated in another clinical trial within 30 days prior to screening in which you have received an investigational drug.
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
have donated a pint of blood within 56 days before the first dose of study drug.
Descrição

Blood Donation pint

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0560012
have any known or suspected stomach condition (or stomach surgery within the 6 months prior to dosing).
Descrição

Medical condition Stomach | Medical condition Stomach Suspected | Operation on stomach

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0038351
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0038351
UMLS CUI [2,3]
C0750491
UMLS CUI [3]
C0192398
have abnormal liver test results.
Descrição

Liver test abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0745768
have a documented history or diagnosis of cirrhosis.
Descrição

Liver Cirrhosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023890
have positive results for hepatitis c or b, or hiv at screening.
Descrição

Hepatitis C positive | Hepatitis B positive | HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1112419
UMLS CUI [2]
C0856706
UMLS CUI [3]
C0019699
have blood pressure outside of the normal range.
Descrição

Abnormal blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005826
are a male subject who is unwilling to either abstain from sexual activity or unwilling to use birth control during the course of the study.
Descrição

Gender Sexual Abstinence Unwilling | Gender Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036899
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
are using non-prescription drugs, vitamins, herbal or dietary supplements (including st john's wort) within 7 days before the first dose of study medication,
Descrição

Non-Prescription Drugs Use of | Vitamins | Herbal supplement | Dietary Supplements | ST. JOHN'S WORT EXTRACT

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C1524063
UMLS CUI [2]
C0042890
UMLS CUI [3]
C1504473
UMLS CUI [4]
C0242295
UMLS CUI [5]
C0813171
have any abnormality identified on the screening physical or laboratory examination that the study physician feels would make it inappropriate for you to participate in the study.
Descrição

Abnormality Study Subject Participation Status Inappropriate | Physical Examination | Laboratory examination

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0260877
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00501397

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Healthy | Non-smoker
Item
are a healthy, non-smoking male or female.
boolean
C3898900 (UMLS CUI [1])
C0337672 (UMLS CUI [2])
Age
Item
are 18 to 55 years old, inclusive.
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
have a body weight of > or equal to 110 pounds.
boolean
C0005910 (UMLS CUI [1])
Gender Childbearing Potential Lacking | Gender Pregnancy test negative
Item
are a female who is unable to have any more children and have a negative pregnancy test.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
Informed Consent
Item
are willing and able to provide written informed consent before the start of any study-related procedures.
boolean
C0021430 (UMLS CUI [1])
Comprehension Study Protocol | Protocol Compliance
Item
are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Tobacco use
Item
smoke or use any tobacco products.
boolean
C0543414 (UMLS CUI [1])
Ketoconazole allergy | Allergic Reaction Investigational New Drugs
Item
have a known allergic reaction to ketoconazole or study drug.
boolean
C0571275 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Alcohol consumption Regular Alcoholic drink Weekly | Gender
Item
have a history of regular alcohol consumption greater than 7 drinks per week for females or greater than 14 drinks per week for males.
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])
Blood-drug tests Positive | Blood alcohol test positive | Smoking Test Positive
Item
have a positive drug or alcohol or smoking test at screening or check-in to the clinic.
boolean
C0868677 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0948726 (UMLS CUI [2])
C0037369 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs
Item
have participated in another clinical trial within 30 days prior to screening in which you have received an investigational drug.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Blood Donation pint
Item
have donated a pint of blood within 56 days before the first dose of study drug.
boolean
C0005794 (UMLS CUI [1,1])
C0560012 (UMLS CUI [1,2])
Medical condition Stomach | Medical condition Stomach Suspected | Operation on stomach
Item
have any known or suspected stomach condition (or stomach surgery within the 6 months prior to dosing).
boolean
C3843040 (UMLS CUI [1,1])
C0038351 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0038351 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
C0192398 (UMLS CUI [3])
Liver test abnormal
Item
have abnormal liver test results.
boolean
C0745768 (UMLS CUI [1])
Liver Cirrhosis
Item
have a documented history or diagnosis of cirrhosis.
boolean
C0023890 (UMLS CUI [1])
Hepatitis C positive | Hepatitis B positive | HIV Seropositivity
Item
have positive results for hepatitis c or b, or hiv at screening.
boolean
C1112419 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Abnormal blood pressure
Item
have blood pressure outside of the normal range.
boolean
C0005826 (UMLS CUI [1])
Gender Sexual Abstinence Unwilling | Gender Contraceptive methods Unwilling
Item
are a male subject who is unwilling to either abstain from sexual activity or unwilling to use birth control during the course of the study.
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Non-Prescription Drugs Use of | Vitamins | Herbal supplement | Dietary Supplements | ST. JOHN'S WORT EXTRACT
Item
are using non-prescription drugs, vitamins, herbal or dietary supplements (including st john's wort) within 7 days before the first dose of study medication,
boolean
C0013231 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0042890 (UMLS CUI [2])
C1504473 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0813171 (UMLS CUI [5])
Abnormality Study Subject Participation Status Inappropriate | Physical Examination | Laboratory examination
Item
have any abnormality identified on the screening physical or laboratory examination that the study physician feels would make it inappropriate for you to participate in the study.
boolean
C1704258 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2])
C0260877 (UMLS CUI [3])
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