ID

39270

Descrição

Study of the Product QGC001 as a Single Dose and Multiple Doses Administered Orally to Healthy Adult Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01900184

Link

https://clinicaltrials.gov/show/NCT01900184

Palavras-chave

Versões (1)
  1. 15/12/2019 15/12/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

15 de dezembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT01900184

Inglês

Eligibility Essential Hypertension NCT01900184

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
caucasian, male healthy subjects of 18 to 45 years of age (inclusive).
Descrição

Caucasians | Gender | Healthy Volunteers | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0043157
UMLS CUI [2]
C0079399
UMLS CUI [3]
C1708335
UMLS CUI [4]
C0001779
body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening.
Descrição

Body Weight | Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
subjects will sign and date an informed consent form before any study-specific screening procedure is performed.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ecg readings.
Descrição

Healthy Medical History | Healthy Physical Examination | Healthy Laboratory test result | Healthy Vital signs measurements | Healthy 12 lead ECG

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C3898900
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C3898900
UMLS CUI [3,2]
C0587081
UMLS CUI [4,1]
C3898900
UMLS CUI [4,2]
C2963216
UMLS CUI [5,1]
C3898900
UMLS CUI [5,2]
C0430456
non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. must be able to abstain from smoking during the inpatient stay.
Descrição

Non-smoker | Tobacco use Number of cigarettes per day | Ability Refrain from Smoking

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0543414
UMLS CUI [2,2]
C3694146
UMLS CUI [3,1]
C0085732
UMLS CUI [3,2]
C4086797
have a high probability for compliance with and completion of the study.
Descrição

Probability High Compliance behavior | Probability High Completion of clinical trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0033204
UMLS CUI [1,2]
C0205250
UMLS CUI [1,3]
C1321605
UMLS CUI [2,1]
C0033204
UMLS CUI [2,2]
C0205250
UMLS CUI [2,3]
C2732579
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy.
Descrição

Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Gastrointestinal Diseases | Endocrine System Diseases | Immune System Diseases | Dermatologic disorders | Hematological Disease | Nervous system disorder | Mental disorders | Drug Allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0035204
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0021053
UMLS CUI [8]
C0037274
UMLS CUI [9]
C0018939
UMLS CUI [10]
C0027765
UMLS CUI [11]
C0004936
UMLS CUI [12]
C0013182
acute disease state within 7 days before study day 1.
Descrição

Acute illness

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4061114
history of drug abuse within 1 year before study day 1.
Descrição

Drug abuse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013146
history of alcoholism within 1 year before day 1. consumption of more than 50 g of ethanol per day.
Descrição

Alcoholic Intoxication, Chronic | Alcohol consumption Gram per day

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0439417
positive serologic findings for human immunodeficiency virus antibodies, hepatitis b surface antigen, and/or hepatitis c virus antibodies.
Descrição

Serology positive HIV Antibodies | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C Antibodies

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019683
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019168
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0166049
positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, mdma)
Descrição

Urine drug screen positive | Amphetamines | Barbiturates | Benzodiazepines | Cannabinoids | Cocaine | Methadone | Opiates | Ecstasy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0002667
UMLS CUI [3]
C0004745
UMLS CUI [4]
C0005064
UMLS CUI [5]
C0006864
UMLS CUI [6]
C0009170
UMLS CUI [7]
C0025605
UMLS CUI [8]
C0376196
UMLS CUI [9]
C0115471
history of any clinically important drug allergy.
Descrição

Drug Allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013182
prohibited treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration.
Descrição

Therapeutic procedure Illicit | Investigational New Drugs Recent | Prescription Drugs Recent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332266
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0304227
UMLS CUI [3,2]
C0332185
consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
Descrição

Pharmaceutical Preparations Containing Caffeine | Consumption Excessive cups per day | GRAPEFRUIT EXTRACT | Pharmaceutical Preparations Containing GRAPEFRUIT EXTRACT | Alcoholic Beverages

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0006644
UMLS CUI [2,1]
C0009830
UMLS CUI [2,2]
C0442802
UMLS CUI [2,3]
C0560654
UMLS CUI [3]
C0440280
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0332256
UMLS CUI [4,3]
C0440280
UMLS CUI [5]
C0001967
use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration.
Descrição

Drugs, Non-Prescription | Herbal Supplements | Exception Acetaminophen | Exception Aspirin | Exception Vitamins

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C1504473
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0000970
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0004057
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0042890
donation of blood (i.e. 450 ml) within 90 days before study day 1.
Descrição

Blood Donation Amount Timespan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
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Similar models

Eligibility Essential Hypertension NCT01900184

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Caucasians | Gender | Healthy Volunteers | Age
Item
caucasian, male healthy subjects of 18 to 45 years of age (inclusive).
boolean
C0043157 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C1708335 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
Body Weight | Body mass index
Item
body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Informed Consent
Item
subjects will sign and date an informed consent form before any study-specific screening procedure is performed.
boolean
C0021430 (UMLS CUI [1])
Healthy Medical History | Healthy Physical Examination | Healthy Laboratory test result | Healthy Vital signs measurements | Healthy 12 lead ECG
Item
healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ecg readings.
boolean
C3898900 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3898900 (UMLS CUI [3,1])
C0587081 (UMLS CUI [3,2])
C3898900 (UMLS CUI [4,1])
C2963216 (UMLS CUI [4,2])
C3898900 (UMLS CUI [5,1])
C0430456 (UMLS CUI [5,2])
Non-smoker | Tobacco use Number of cigarettes per day | Ability Refrain from Smoking
Item
non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. must be able to abstain from smoking during the inpatient stay.
boolean
C0337672 (UMLS CUI [1])
C0543414 (UMLS CUI [2,1])
C3694146 (UMLS CUI [2,2])
C0085732 (UMLS CUI [3,1])
C4086797 (UMLS CUI [3,2])
Probability High Compliance behavior | Probability High Completion of clinical trial
Item
have a high probability for compliance with and completion of the study.
boolean
C0033204 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0033204 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Gastrointestinal Diseases | Endocrine System Diseases | Immune System Diseases | Dermatologic disorders | Hematological Disease | Nervous system disorder | Mental disorders | Drug Allergy
Item
any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy.
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0021053 (UMLS CUI [7])
C0037274 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0027765 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0013182 (UMLS CUI [12])
Acute illness
Item
acute disease state within 7 days before study day 1.
boolean
C4061114 (UMLS CUI [1])
Drug abuse
Item
history of drug abuse within 1 year before study day 1.
boolean
C0013146 (UMLS CUI [1])
Alcoholic Intoxication, Chronic | Alcohol consumption Gram per day
Item
history of alcoholism within 1 year before day 1. consumption of more than 50 g of ethanol per day.
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
Serology positive HIV Antibodies | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C Antibodies
Item
positive serologic findings for human immunodeficiency virus antibodies, hepatitis b surface antigen, and/or hepatitis c virus antibodies.
boolean
C0242089 (UMLS CUI [1,1])
C0019683 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019168 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0166049 (UMLS CUI [3,2])
Urine drug screen positive | Amphetamines | Barbiturates | Benzodiazepines | Cannabinoids | Cocaine | Methadone | Opiates | Ecstasy
Item
positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, mdma)
boolean
C0743300 (UMLS CUI [1])
C0002667 (UMLS CUI [2])
C0004745 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C0006864 (UMLS CUI [5])
C0009170 (UMLS CUI [6])
C0025605 (UMLS CUI [7])
C0376196 (UMLS CUI [8])
C0115471 (UMLS CUI [9])
Drug Allergy
Item
history of any clinically important drug allergy.
boolean
C0013182 (UMLS CUI [1])
Therapeutic procedure Illicit | Investigational New Drugs Recent | Prescription Drugs Recent
Item
prohibited treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration.
boolean
C0087111 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0304227 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
Pharmaceutical Preparations Containing Caffeine | Consumption Excessive cups per day | GRAPEFRUIT EXTRACT | Pharmaceutical Preparations Containing GRAPEFRUIT EXTRACT | Alcoholic Beverages
Item
consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
boolean
C0013227 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0006644 (UMLS CUI [1,3])
C0009830 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
C0560654 (UMLS CUI [2,3])
C0440280 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0332256 (UMLS CUI [4,2])
C0440280 (UMLS CUI [4,3])
C0001967 (UMLS CUI [5])
Drugs, Non-Prescription | Herbal Supplements | Exception Acetaminophen | Exception Aspirin | Exception Vitamins
Item
use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration.
boolean
C0013231 (UMLS CUI [1])
C1504473 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0004057 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0042890 (UMLS CUI [5,2])
Blood Donation Amount Timespan
Item
donation of blood (i.e. 450 ml) within 90 days before study day 1.
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
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